MANAGEMENT OF NON- COELIAC GLUTEN SENSITIVITYcongress.metagenics.com.au/postcongress/media/... ·...
Transcript of MANAGEMENT OF NON- COELIAC GLUTEN SENSITIVITYcongress.metagenics.com.au/postcongress/media/... ·...
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MANAGEMENT OF NON-COELIAC GLUTEN SENSITIVITY
Dr Sue Shepherd B.App.Sci. (Health Promotion), M. Nut & Diet., PhD.
Advanced Accredited Practising Dietitian
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REPRESENTATIONS AND AFFILIATIONS
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DISCLOSURE • Author of Cookbooks for Coeliac Disease and IBS.
– “Irresistibles for the Irritable”, “Two Irresistible for the Irritable”, “Gluten Free Cooking”, “The Gluten Free Kitchen”, “Allergy Free Cooking”, “Food Intolerance Management Plan”, “Gluten and Wheat Free Diabetes”, “Low FODMAP Recipes”, and “The Complete Low FODMAP Diet”.
• Co-author of “Gastrointestinal Nutrition”. – Resource manual for dietetic management of gastrointestinal conditions.
• Consultant to Gluten Free Food Show in Melbourne, Sydney, Brisbane, Launceston. – for coeliac disease, low FODMAP diet.
• Consultant dietitian to food companies for development of specialty food products.
• Co-ownership of FODMAP Friendly certification trademark. • Co-director of company producing FODMAP Friendly food
products.
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CHARACTERISTICS OF PATIENTS WITH NON-COELIAC GLUTEN SENSITIVITY
• Functional gut symptoms (IBS-like) e.g., abdominal bloating, excess wind, altered bowel habits, abdominal pain.1,2
• Systemic manifestations e.g. “foggy head”, headache, fatigue, joint and muscle pain, leg or arm numbness, dermatitis, depression.1,2
• Symptoms improve on gluten withdrawal. • Symptoms worsen on gluten consumption.
1. Ludvigsson et al, Gut 2012. 2. Catassi et al, 2013
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CHARACTERISTICS OF PATIENTS WITH NON-COELIAC GLUTEN SENSITIVITY
• No standard diagnostic approach to NCGS.1,2 • Systematic evaluation recommended. • Exclude CD (either normal duodenal histology on
gluten or absence of HLA DQ2 or DQ8 genotype). • Exclude wheat allergy; and • Exclude other inflammatory disorders as appropriate.
• No major complications of untreated NCGS have been described. Natural history data lacking.2
1. Ludvigsson et al, Gut 2012. 2. Catassi et al, 2013
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CHARACTERISTICS OF PATIENTS WITH NON-COELIAC GLUTEN SENSITIVITY
• Non-coeliac gluten sensitivity has been estimated to affect 0.5-6% of the population.1,2
• In Australia, it is estimated that for every person with diagnosed coeliac disease, there are twenty others eating gluten-free food.3
1. www.massgeneral.org/children/services/celiac-disease/gluten-sensitivity-faq.aspx 2. Catassi et al, 2013. 3. Vinning & McMahon. Rural Industries Research &
Development Corp, Aust Govt, 2006.
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DOES NON-COELIAC GLUTEN SENSITIVITY EXIST?
1 Ludvigsson et al, Gut 2012.
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NON-COELIAC GLUTEN SENSITIVITY – THE LITERATURE
A mixed bag!..... • Some studies have had inappropriate inclusion criteria e.g.,
patients with increased density IELs. 1
• Increasing risk that patients with latent coeliac disease were included in study.
• IBS cases may be classified as NCGS.2 • Terminology issues – “wheat sensitivity”, “gluten sensitivity”,
“gluten intolerance”, “non-coeliac gluten sensitivity”, etc. • Wheat contains many constituents that could play a role in
triggering symptoms – amylase-trypsin inhibitors (new area of interest – release pro-inflammatory cytokines), fructans (FODMAP), proteins (allergy). These need to be controlled for in studies. 1. Wahnschaffe et al, 2001. Catassi et al, 2013
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DOES NON-COELIAC GLUTEN SENSITIVITY EXIST?
• Carroccio et al conducted a study in 2012 in a cohort of 920 patients with IBS.
• Participants undertook a 4 week gluten free (elimination) diet then double-blinded crossover rechallenge with wheat or placebo capsules.
• 276 participants (30%) had “wheat sensitivity”. 206 of these (75%) had multiple food sensitivities.
• Confusion re: terminology. • Uncertain if it was gluten withdrawal or other factor
that benefited participants. Carroccio et al 2012
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DOES NON-COELIAC GLUTEN SENSITIVITY EXIST?
• Biesiekierski et al conducted a double blinded, randomised, placebo-controlled rechallenge trial on 34 patients (29-59y, 4 men) with IBS (self-controlled on a GFD)1.
• CD excluded: negative coeliac serology AND either an HLA DQ2/8 negative or normal duodenal biopsy.
• Patients were given either gluten (1 muffin and 2 slices bread = 16g gluten) or placebo for 6 weeks. These were also low FODMAP.
• Background diet not controlled. 1. Biesiekierski JR, et al 2011
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DOES NON-COELIAC GLUTEN SENSITIVITY EXIST?
• The group given gluten demonstrated a significant deterioration of symptoms compared to placebo (85% vs 40% p=0.0001).
• Symptoms included abdominal pain, bloating, satisfaction with stool consistency, and tiredness.
• There was no difference between the groups in tests for intestinal injury (faecal lactoferrin, CRP or sugar test for intestinal permeability) or coeliac serology.
• We were unable to elucidate a mechanism for the difference between the groups.
Biesiekierski JR, et al 2011
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DOES NON-COELIAC GLUTEN SENSITIVITY EXIST?
Recently… • A double-blind placebo-controlled cross-over
trial in patients with self-reported NCGS has produced contradicting results, raising some doubt about the existence of NCG.
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DOES NON-COELIAC GLUTEN SENSITIVITY EXIST?
• Biesiekierski et al. recruited 37 patients with IBS and self-reported NCGS. 1
• CD excluded: negative coeliac serology AND either a HLA DQ2/8 negative or normal duodenal biopsy (identical inclusion/exclusion criteria as the 2011 study).2
• Recruits were provided all meals during the study and undertook all three treatment arms, in a cross-over study with >2 week washout periods between arms.
1. Biesiekierski JR, et al 2013 2. Biesiekierski JR, et al 2011
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High gluten (16g/gluten)
Low Gluten (2g gluten/ 14g whey)
Control (0g gluten/ 16g whey)
≥2 week washout ≥ 2 week washout
7 days 7 days 7 days
← Low FODMAP Diet →
Low FODMAP
Diet
14 days n=37 – STUDY PART A
Visual Analogue Scale (VAS) symptom scores
Biesiekierski JR, et al 2013
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Mean +/- SEM
*
*
* *
* = <0.05 from end of low FODMAP run-in to end of treatment arm Biesiekierski JR, et al 2013
CHANGES IN SYMPTOM SEVERITY FROM RUN-IN FOR EACH 7 DAY
DIETARY TREATMENT
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Mean +/- SEM
*
*
* *
* = <0.05 from end of low FODMAP run-in to end of treatment arm
In all participants, gastrointestinal symptoms significantly worsened to a similar degree when their diets included
gluten or whey protein.
Gluten-specific effects were observed in only 8% of participants.
There were no diet-specific changes in any biomarker (serum
and faecal markers of intestinal inflammation/injury).
Biesiekierski JR, et al 2013
CHANGES IN SYMPTOM SEVERITY FROM RUN-IN FOR EACH 7 DAY
DIETARY TREATMENT
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Gluten arm (16g gluten/
0g whey)
Whey arm (0g gluten/ 16g whey)
Control (0g gluten/ 0g whey)
≥3 day washout ≥ 3 day washout
3 days 3 days 3 days
← Low FODMAP, Low Food chemical, Dairy Free Diet →
• No differences across dietary treatment arms for change in overall symptoms (day 3) vs baseline period (PART A).
• Changes in individual symptoms (e.g., bloating, satisfaction with stool consistency, wind, pain, tiredness, and nausea) were similar across the 3 dietary periods (all p > 0.209).
Biesiekierski JR, et al 2013
n=37 – STUDY PART B
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RESULTS • All participant’s symptoms improved on reduction in
FODMAPs prior to the delivery of treatment arms. • There was no difference in VAS symptom scores
between gluten, whey and/or placebo arms.
• The study demonstrated a significant placebo effect
as all treatment groups experienced an increase in symptoms during each of the treatment arms.
Biesiekierski JR, et al 2013
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DIFFERENCES IN STUDY DESIGN 2011 VS 2013
Factor Protocol in 2011
Change in 2013 Rationale
Access to food during study
Regular diet. Only muffins and bread provided.
All meals provided – low FODMAP and gluten free
To reduce “background noise”. To control for changes in participant’s usual diet including FODMAP intake.
Consideration of other putative triggers for gut symptoms
Nil Restriction of dairy products and all food chemicals.
Ensured that during Part B, the only difference between treatment arms was the nature of the protein intake.
Study design Parallel Cross-over To reduce influence of confounders and increase power.
Duration of treatment
6 weeks 1 week – part A 3 days – part B
Symptoms peaked at day 3, unlikely longer time frame would capture delayed response to gluten
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DOES NON-COELIAC GLUTEN SENSITIVITY EXIST IN PATIENTS
WITH FUNCTIONAL GUT SYMPTOMS?
“In these two double-blind, randomised, placebo-controlled, cross-over trials
(Part A and B), specific and reproducible induction of symptoms with gluten could not be
demonstrated”.
Answer: ??
Biesiekierski JR, et al 2013
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• These data suggest that NCGS may not be a discrete entity; or
• NCGS might be confounded by FODMAP restriction.
• As suggested by this highly selected cohort, gluten might be not be a specific trigger of functional gut symptoms once dietary FODMAPs are reduced.
Biesiekierski JR, et al 2013
CONCLUSION
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DOES NON-COELIAC GLUTEN SENSITIVITY EXIST IN PATIENTS
WITH EXTRA-GASTROINTESTINAL SYMPTOMS?
Randomised Clinical Trial: gluten may cause depression in subjects with non-coeliac gluten
sensitivity – an exploratory clinical study.
Answer: unfolding
Peters S, et al 2014
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CHARACTERISATION OF ADULTS WITH A SELF-DIAGNOSIS OF
NON-COELIAC GLUTEN SENSITIVITY
Jessica Biesiekierski, Evan Newnham, Susan Shepherd, Jane Muir and Peter Gibson
Nutrition in Clinical Practice, in press 2014
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• Non-coeliac gluten sensitivity (NCGS), is a condition where patients without coeliac disease report gastrointestinal symptoms improve on a gluten-free diet (GFD).
• NCGS is largely a self-reported diagnosis. • NCGS appears to be very common. • Aim: To characterise patients who believed they
have NCGS.
BACKGROUND AND AIM
Biesiekierski JR, et al 2014
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PARTICIPANTS
• 147 recruits (mean age 43.5yrs, 88% female). • Believed they had NCGS. • Completed a questionnaire about symptoms,
diet and coeliac investigation.
Biesiekierski JR, et al 2014
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STUDY DESIGN - QUESTIONNAIRE • 23 questions, three domains:
• Symptoms: e.g. • ‘Describe your main symptoms if you eat gluten’ • ‘Do you currently feel in control of your
symptoms?’ • Diet: e.g.
• ‘Do you follow a strict gluten free diet?’ • ‘How long have you been following a gluten free
diet?’ • ‘Where did you find out about a gluten free diet?’
Biesiekierski JR, et al 2014
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STUDY DESIGN - QUESTIONNAIRE • Coeliac Disease Investigation: e.g:
• ‘Have you had blood tests (or “coeliac antibodies”) for diagnosis of coeliac disease?’
• ‘Have you had the gene test for coeliac disease?’ • ‘Have you had a gastroscopy (endoscopy) for diagnosis
of coeliac disease?’ • ‘If yes, were you consuming gluten in the lead up to
the gastroscopy? • How much gluten and for how long before the
gastroscopy were you eating gluten? • Were you specifically asked to consume gluten in the
lead up to the gastroscopy?’ Biesiekierski JR, et al 2014
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RESULTS - PARTICIPANT PRESENTATION
NCGS 28%
Not NCGS 72%
Only 28% of people completing the
survey fulfilled the criteria of NCGS.
- Inadequate exclusion of coeliac
disease 62%. - Uncontrolled
symptoms despite gluten restriction
24%. - Not following a
GFD 27%.
40 of these patients were enrolled in the Biesiekierski
(PART A/B) study described earlier.
Biesiekierski JR, et al 2014
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RESULTS – COELIAC INVESTIGATIONS Adequacy of coeliac disease exclusion based
on source for initiating the GFD.
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Self Alt practrs Dietitians GPs
Inadequate exclusion of CD
Adequate exclusion of CD
91/147 (62%) did not have coeliac disease adequately
excluded
Source of referral
n=65 n=30 n=28 n=24
Biesiekierski JR, et al 2014
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RESULTS - SYMPTOMS “Do you currently feel in control of your symptoms”
NO (22%)
SOMETIMES (7%)
MOSTLY (12%)
YES (59%)
Almost 1 in 4 don’t feel in control of symptoms on GFD –
nonsensical to presume issue is NCGS
41% have incomplete
resolution of symptoms on GFD
Biesiekierski JR, et al 2014
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• Only 28% self-reporting as NCGS fulfill criteria for its diagnosis. • Ensuring criteria fulfilled is essential prior to recruitment for
any studies to be useful. • Initiation of a GFD without adequate exclusion of
coeliac disease is common. • Coeliac disease MUST be excluded. Excluding wheat allergy
also useful. • In 22%, symptoms are poorly controlled despite gluten
avoidance (and 40% have inadequate control). • Excluding potential for other common dietary triggers
recommended, e.g., FODMAPs. Biesiekierski JR, et al 2014
SUMMARY OF FINDINGS
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NCGS PATIENT DIAGNOSIS
FLOWCHART
Step 1. Adequate
exclusion of CD
Step 2. Other dietary triggers
excluded ie. FODMAPS
Step 3. Controlled symptoms with gluten restriction
Step 4. Symptoms
induced with gluten
rechallenge
Step 5. Establish
threshold of gluten
tolerance
Non-coeliac gluten
sensitivity
Biesiekierski JR, et al 2014
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Step 1: Definitive exclusion of coeliac disease done by either absence of the coeliac-associated HLA-DQ genotype or negative coeliac serology and a normal duodenal biopsy on a gluten-rich diet. (Also exclude any other pathological causes for symptoms where appropriate). Step 2: After testing for coeliac disease, other possible dietary triggers should be investigated, importantly Fermentable Oligo- Di- and Mono-saccharides And Polyols (FODMAPs), by initiating and trialing the low FODMAP diet for 6 weeks. Skilled educator (e.g., nutritionist) is imperative.
NCGS PATIENT MANAGEMENT FLOWCHART
Biesiekierski JR, et al 2014
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Step 3: If the patient experiences no or partial symptom improvement to the low FODMAP diet, it is then worth considering gluten. Patients should exclude dietary gluten for 4 weeks and record symptom response. Step 4: Provided there is marked improvement in symptoms with the GFD, blinded challenges (that is, monitored reintroduction of gluten) can be subsequently undertaken.
NCGS PATIENT MANAGEMENT FLOWCHART
Biesiekierski JR, et al 2014
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Step 5: Following a positive challenge, the amount of gluten tolerated should be established by systematic re-challenges beginning with small amounts of gluten.
NCGS PATIENT MANAGEMENT FLOWCHART
Biesiekierski JR, et al 2014
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PRACTICAL IMPLICATIONS • Those fulfilling NCGS criteria (~40 in Biesiekierski et al 2013
study), experienced a superior response to reduced FODMAP diet compared with gluten restriction.
• As a cause for functional gut symptoms, IBS is more common than NCGS (10-20% vs 0.5-6%), therefore the low FODMAP diet should have greater likelihood to offer symptom relief than the gluten free diet. • Supported by Biesiekierski et al study.
• In the patient who has had coeliac disease excluded and believes they have NCGS, however still has GI symptoms despite GFD compliance, consider FODMAP intolerance.
Biesiekierski JR, et al 2013
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CASE STUDY • Ms M.N., 37 y.o. female on gluten free diet
(GFD) for 18 months to manage bloating, excessive wind, abdominal pain.
• Self-initiated GFD. • No previous coeliac disease investigations
(biopsy or gene test). • Increased frequency of bloating, wind and
altered bowel actions for past 8 months. • Self-referred to nutritionist.
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CASE STUDY • Diet history confirms MN is on strict GFD with
only occasional gluten intake (beer, cornflakes, rye bread). Diet also has regular intake of high FODMAP foods.
• Dietitian discusses with patient the possibility symptoms could be due to coeliac disease. – MN not keen to undergo gluten challenge as reports
she feels better without gluten. • Gluten challenge = 4 slices wheat bread/day for 6 weeks.
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CASE STUDY • MN agreeable to have HLA testing ordered through
GP: – If DQ2 and/or DQ8 negative, it rules out CD. – If positive, it does not diagnose CD, only indicates MN
has the genetic potential to get CD. • If positive, would recommend gluten challenge followed up
with coeliac serology and referral to gastroenterologist for consideration of small bowel biopsy.
• While waiting for HLA blood tests to be done and results returned, MN is taught to combine the GFD and the strict low FODMAP diet (phase 1).
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EXAMPLES OF HIGH FODMAP FOODS Excess Fructose Polyols Lactose Fructans Galacto-
oligosaccharides
Apples, pears, mangoes, nashi fruit, boysenberry, watermelon, cherries, asparagus, Jerusalem artichokes, sugar snap peas, honey, high fructose corn syrup, agave.
Apple, apricot, avocado, blackberry, cherry, nashi fruit, peach, pear, plum, prune, watermelon, cauliflower, mushrooms
Milk, ice cream, custard, yoghurt, ricotta cheese, cream cheese, cottage cheese.
Custard apple, persimmon, nectarine, watermelon, globe artichoke, asparagus, garlic, legumes, lentils, leek, onion, shallot, spring onion (white part), cashew, pistachio, wheat, rye, barley (in large amounts).
Legumes, lentils, chickpeas.
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EXAMPLES OF LOW FODMAP FOODS Fruit* Vegetables Cereals and
Grains Milk Products Other foods
Banana, kiwifruit, strawberry, blueberry, orange, mandarin, lemon, lime, honeydew melon, grapes, pineapple, passionfruit. *Limit serving size.
Potato, carrot, spinach, capsicum, eggplant, zucchini, lettuce, tomato, cucumber, turnip, swede, green beans, parsnip, squash
Rice, cornflour, quinoa, millet, sorghum, oats, polenta.
Lactose free milk, lactose free yoghurt, fermented cheeses (block cheese) e.g., parmesan, cheddar, gouda, edam, brie, camembert, fetta, mozzarella. Small amounts of cream and soft cheeses.
Sugar, maple syrup, golden syrup. Small handful of nuts and seeds (all except cashews and pistachios), unprocessed meat, fish, chicken, eggs. Garlic-infused olive oil.
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CASE STUDY • MN returns to dietitian in 4wks. She reports symptom resolution on combined
GFD and strict low FODMAP diet (Phase 1). • HLA results returned negative result (no HLA-DQ2 or 8).
– Coeliac disease excluded.
• MN keen to continue low FODMAP diet and willing to reintroduce gluten slowly. Instructed to monitor symptoms and continue to restrict all FODMAPs. – High gluten/low FODMAP foods include oats, some spelt breads, small amounts of
wheat, rye, barley.
• MN returns to nutritionist in 4 wks. Reports gluten reintroduced successfully, no symptoms experienced. Strict low FODMAP diet alone effective for symptom management.
• MN then instructed on Phase 2 of the low FODMAP diet (liberalisation phase) to ensure no unnecessary over-restriction.
• After 8wks Phase 2, MN very satisfied with symptom control, increased variety in her diet and increased understanding of her symptom triggers.
If gene test was positive, it does not exclude coeliac disease. So, you can
instruct MN to undergo gluten challenge with low FODMAP/high
gluten foods: -Small amounts of wheat
- Some 100% spelt breads - Oats
- As these are low FODMAP, they will minimise symptom insult,
whilst still providing gluten load.
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FUTURE DIRECTIONS • There is a need for large multi-centre studies
investigating the role of gluten in NCGS, which account for potential confounding symptom triggers e.g., FODMAPs (and potentially wheat ATIs).
• Such studies may then further define NCGS and enable researchers to establish: – True prevalence figures. – Existence of variation in threshold of sensitivity to gluten. – If it is long term condition or temporary/transient.
Catassi et al. 2013