Gluten powder (10 g every 12 hours), 24 weeks

Placebo (maltodextrin; 10 g every 12 hours), 24 weeks

Celiac Disease

Non-celiac Gluten Sensitivity

gluten (20 g/day) (identical powder sachets than placebo, mixed with meals) rechallenge while on a gluten-free diet

Gluten challenge

placebo (maltrodextrin) (identical powder sachets than gluten, mixed with meals) rechallenge while on a gluten-free diet

Placebo challenge

Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo

Lymphocytic Enteritis and Suspected Coeliac Disease: Double-blind Gluten vs Placebo Rechallenge

Visual analogue scale on clinical symptoms at each visit (Baseline, 4 weeks, 12 weeks, 24 weeks)

GI quality of life index (GIQLI) at basal and 24 week visits

Changes in intraepithelial lymphocyte count

Changes in cytometric count of gamma/delta cells

Fernando Fernandez-Bañares

Hospital Mutua de Terrassa

Low FODMAP dietary advice; participants to supplement diet with oligofructose, a poorly digested carbohydrate that will restore FODMAP content to the diet.

Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate)

Post-infective Bowel Dysfunction

Functional Gastrointestinal Disorders

An education session with a specialist dietitian, and provision of written advice, on how to follow the low FODMAP diet. Second session after one month on re-introduction of FODMAP containing foods.

low FODMAP dietary advice

Dietary supplementation with maltodextrin 5 grams twice daily for a month

Maltodextrin

Dietary supplementation with oligofructose 5 grams twice daily for a month

Oligofructose

University of Nottingham

Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates

A Pilot Double Blind, Randomised, Placebo Controlled Trial of the Effect of a Diet Low in Poorly Digested Carbohydrates on Symptoms of Post-infective Bowel Dysfunction

The IBS-GIS (Irritable Bowel Syndrome Global Improvement Score) is a validated 7-point balance scale to assess change in perception of symptoms in functional bowel disorders. Points 6 and 7 on the scale refer to moderate or substantial improvement. The outcome measure will be the proportion of participants in each group marking point 6 or 7 on the balance scale at this time point.

Response to a yes/no question "Have your symptoms been adequately controlled?"

Percentage of days with at least one stool of consistency type 6 or 7 on the Bristol stool form scale

The IBSS (Irritable Bowel Symptom Severity Scale) is a validated composite score of symptoms in functional intestinal disorders

This is a mechanistic endpoint. Colonic volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.

This is a mechanistic endpoint. Colonic gas volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.

This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention

The EQ5D is a validated questionnaire to measure quality of life

This will be exploratory work to assess the effect of the diet on other constituents of the stool microbiota

Nottingham University Hospitals NHS Trust

King's College London

Patients with a positive lactose-breath test and complaints during the test

Patients with a positive lactose-breath test and no complaints during the test

Subjects with a negative lactose-breath test

Lactose Intolerance

TARGID, KU Leuven

Comparison of the Colonic Metabolism in Patients With Lactose Intolerance and Healthy Controls

Fecal water, prepared by ultracentrifugation of fecal samples, will be incubated with HT-29 cells, a colonic adenocarcinoma cell line. Fecal water genotoxicity will be assessed using the Comet Assay, a sensitive method to detect DNA damage at the level of the individual eukaryotic cell. During the Comet Assay, the cells undergo electrophoresis causing movement of the damaged DNA out of the nucleus. The amount of DNA damage will be determined by measuring the extent the DNA has moved out of the nucleus, using fluorescent microcropy and dedicated software.

Fecal water cytotoxicity will be measured using the WST-1 assay, a colorimetric test based on the conversion of the tetrazolium salt WST-1 by cellular mitochondrial dehydrogenases present in viable cells. The dilution of fecal water at which 50% of the cells survive will be determined. The higher the dilution, the more cytotoxic the sample is.

Kristin Verbeke

Professor Kristin Verbeke

KU Leuven

Maltodextrin (non-prebiotic carbohydrate).

Radiation Enteritis

Radiation Proctitis

A mixture of 70% oligofructose and 30% inulin.

FructoOligoSaccharide

University College London Hospital

Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.

A Double-blind Placebo-controlled Trial of Dietary Supplementation With 15g/Day FOS for Five Weeks in Patients With Endometrial/Cervical Carcinoma or 7.5 Weeks in Patients With Prostate Carcinoma Undergoing Pelvic Radiotherapy.

To determine whether there is a difference in gastrointestinal status at 5 weeks (enumerated through the Birmingham score) in patients undergoing pelvic irradiation for gynaecological malignancy or at 7.5 weeks in patients undergoing radiotherapy for prostate malignancy given a prebiotic enhanced diet and those on placebo.

To determine the effects of FOS on the short-term toxicity of pelvic irradiation (in comparison to placebo).

To establish the effects of FOS on intestinal integrity, determined endoscopically, biochemically and histologically, after pelvic irradiation, both immediately and at 6 months follow-up

To provide pilot data to determine whether FOS given during pelvic irradiation has an effect on the risk of clinically apparent chronic radiation bowel disease.

To confirm using fluorescence in-situ hybridization (FISH) the changes in the gut microbiota in patients on FOS enhanced diet in comparison with standard diet.

Alastair Forbes Prof.

University College London Hospitals

the reduced-osmolarity WHO-ORS without Benefiber.

Cholera

Benefiber

Benefiber (50 g/L)-supplemented, reduced-osmolarity WHO-ORS

enteritis/carbohydrate

Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo

Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates

Comparison of the Colonic Metabolism in Patients With Lactose Intolerance and Healthy Controls

Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.

Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults

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