FODMAP Reintroduction in Irritable Bowel Syndrome

NCT03245645 | Completed

• 1 other identifier: 16-000934
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the amount and timing of when certain Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAPs), specifically fructose, can be safely reintroduced into the diet of Irritable Bowel Syndrome (IBS) patients that have successfully completed a low-FODMAP elimination diet. The FODMAP diet is an effective treatment for IBS; however it is unclear how patients can successfully reintroduce and liberalize fructose into their diet. The low FODMAP diet is thought to reduce IBS symptoms by decreasing water content and gas production in the bowel and also possibly by altering gut bacteria. Although use of the FODMAP elimination diet can initially successfully treat IBS symptoms for up to 50-75% of patients, the reintroduction diet is difficult for patients to complete and maintain for long periods of time because current methods for reintroduction of FODMAPs are imprecise leading to frequent recurrent symptoms. As a result, patients often continue the low FODMAP elimination diet for additional months because they have difficulties knowing how to add back FODMAPs into their diet. There are no studies to date to help guide patients with FODMAP reintroduction.

Conditions

Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome With Mixed Bowel Habits

Keywords

FODMAP; IBS; Diet; Re-introduction; Fructose

Outcome Measures

Primary Outcomes (2)

• Adequate relief of IBS symptoms in past 7 days

  As indicated by the study coordinator asking the participant "Have you had adequate relief of your IBS symptoms in the past 7 days?"

  Baseline, 4 weeks (post-elimination diet)

• Highest amount of grams of sugar in solutions that do not significantly increase IBS symptoms

  As measured by 100 MM Visual Analog Scale (VAS) with 0 representing no symptoms for overall gastrointestinal symptoms.

  Daily, during weeks 5-7 (reintroduction phase)

Secondary Outcomes (8)

• Change in IBS-symptom severity scale

  Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)

• Change in Visceral Sensitivity Index (VSI)

  Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)

• Change in Personal Health Questionnaire (PHQ-15)

  Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)

• Change in abdominal pain severity

  Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)

• Change in overall severity of gastrointestinal symptoms

  Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)

Study Arms (3)

100% Fructose

EXPERIMENTAL

The fructose group will help to determine whether an absolute amount of fructose will lead to IBS symptoms.

Other: Dietary Intervention

100% Glucose

PLACEBO COMPARATOR

The glucose group will serve as a control since glucose is not a FODMAP and as a result is not expected to lead to recurrent symptoms.

Other: Dietary Intervention

Fructose and Glucose

ACTIVE COMPARATOR

The glucose/fructose mixture group is a cross comparison group that will determine whether the relative excess fructose concentration is an important cause of IBS symptoms.

Other: Dietary Intervention

Interventions

Dietary Intervention OTHER

Food may be linked to changes in motility, visceral sensation, gut microbiome, intestinal permeability, immune activation and brain-gut axis. This study will focus on fructose, which is one of the main components of FODMAP (Fermentable oligosaccharides, dissacharides, mono-saccharides and polyols) foods. Fructose is a common part of the Western diet and can be consumed as a free monosaccharide, part of sucrose, or in polymers referred to as fructans. FODMAP foods are thought to induce gastrointestinal symptoms including gas, bloating, abdominal pain or discomfort, and loose stools by increasing small bowel water content and increasing gas production by fermentation of foods by gut bacteria. Studies including a recent controlled clinical trial demonstrated that a low FODMAP diet can be an effective nutritional therapy.

100% Fructose; 100% Glucose; Fructose and Glucose

Eligibility Criteria

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

You may qualify if:

• Adults (18+ years or older) with a diagnosis of IBS-D or IBS-M based on Rome IV criteria
• Diarrhea must occur 2 or more days per week
• Patients on current pharmacological therapy for their gastrointestinal complaints can enroll in the study as long as they have been on a stable dose for at least 30 days.

You may not qualify if:

• Significant comorbidities that are associated with GI symptoms (e.g. diabetes, scleroderma, SLE), history of GI surgery excluding appendectomy, or prior organic GI illness
• Antibiotics taken in the past 2 months
• Current disordered eating patterns (diagnosed eating disorder; as per verbal ESP questionnaire)
• Current history of greater than moderate alcohol intake (more than 1 drink per day for women, more than 2 drinks per day for men, binge drinking behavior of 5+ drinks in a single session once per week)
• Cannot have had a cholecystectomy in the past 6 months prior to enrollment

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Lin Chang, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Digestive Health and Nutrition Clinic

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 10, 2017
• Study Start: March 24, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Locations

US (1)