Carbohydrate Reduction and Impact on Gastrointestinal System

NCT03729622 | Completed

• 1 other identifier: 15081
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Title : A pilot single blind randomised controlled trial of the effect of a diet low in poorly digested carbohydrates on gastrointestinal form and symptoms in irritable bowel syndrome patients Acronym: CRAIGS Short title: Carbohydrate reduction and impact on gastrointestinal system Chief Investigator: Prof Robin Spiller Objectives: The purpose of this study is to:

• Investigate the proportion of patients with Irritable Bowel Syndrome who report moderate or substantial improvement in their symptoms after 2 weeks of following a diet low in Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAPs) compared to patients who are on their habitual diet.
• Determine the difference in colonic volume of IBS patients receiving immediate low FODMAP dietary intervention after 2 weeks compared to patients who are not on the diet (delayed dietary intervention).
• Investigate the changes in self-reported food intolerance that occurs before dietary intervention. Trial Configuration: 2-arm, parallel group, randomised, controlled trial Setting : Research clinic within NIHR Biomedical Research Unit, Secondary care

Conditions

Irritable Bowel Syndrome

Keywords

FODMAPs; Low FODMAP Diet

Outcome Measures

Primary Outcomes (1)

• Adequate symptom relief between cases and controls

  Adequate symptom relief assessed by questionnaire after intervention in cases and before intervention in cases

  Assessed in cases on their last day of the intervention (2 weeks after dietary change). Assessed in controls before they began their intervention (between 1-2 weeks before dietary changes)

Secondary Outcomes (2)

• Changes in colonic volume between cases and controls from baseline

  Measured : i) baseline (day 0), ii) last day of intervention (cases) (2 weeks after dietary change), iii) before intervention (2 weeks before dietary advice)

• Changes in fermentation between cases and controls

  Measured : i) baseline (day 0), ii) last day of intervention (cases) (2 weeks after dietary change), iii) before intervention (2 weeks before dietary advice)

Study Arms (2)

Immediate Intervention

ACTIVE COMPARATOR

Participants in this arm will receive an immediate low FODMAP dietary intervention on their second visit after they have been screened, consented and enrolled during visit 1.

Other: Low FODMAP Diet

Delayed Intervention

PLACEBO COMPARATOR

Participants in this arm will receive a delayed Low FODMAP dietary intervention during their third visit after they have been been screened, consented and enrolled during visit 1.

Other: Low FODMAP Diet

Interventions

Low FODMAP Diet OTHER

Both arms will receive the intervention but at different time points.

Delayed Intervention; Immediate Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and above
• Able to give informed consent
• Previous Diagnosis of IBS by medical practitioner
• Meeting ROME III criteria for IBS
• Investigations showing negative tissue transglutaminase (tTG) IgA antibodies
• Full blood count test does not indicate Anaemia

You may not qualify if:

• Aged 18 and above
• Able to give informed consent
• Previous Diagnosis of IBS by medical practitioner
• Meeting ROME III criteria for IBS
• Investigations showing negative tissue transglutaminase (tTG) IgA antibodies
• Full blood count test does not indicate Anaemia
• Children (\<18 years)
• History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to:
• Inflammatory Bowel Disease
• Coeliac Disease
• Pancreatitis
• Gallstone disease (biliary colic, cholecystitis)
• Diverticulitis
• Cancer of the gastrointestinal tract
• Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder

Sponsors & Collaborators

• University of Nottingham: lead
• King's College London: collaborator

Study Sites (1)

Nottingham Digestive Diseases Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Robin Spiller, MD,FRCP

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: November 2, 2018
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 2, 2018

Record last verified: 2018-11

Locations

GB (1)