Comparing the Effectiveness of 2 Diets for Patients With Irritable Bowel Syndrome

NCT01624610 | Completed

• 1 other identifier: UMGI-DIETIBS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to find out if the diets often recommended for patients with Irritable Bowel Syndrome with diarrhea (IBS-D) provide adequate relief. The study will compare two diets that are used to treat IBS-D symptoms to see which one is more effective. The study will also measure the effect of these diets on the bowel flora, which are the good bacteria that inhabit the bowels in healthy people.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome; Diarrhea; abdominal pain; diet; nutrition

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with adequate relief.

  Compare the proportion of patients with irritable bowel syndrome (IBS-D) reporting adequate relief on Diet 1 v Diet 2.

  4 weeks

Secondary Outcomes (8)

• Composite endpoint

  4 weeks

• Abdominal Pain

  4 weeks

• Stool consistency

  4 weeks

• Stool frequency

  4 weeks

• Individual symptoms

  4 weeks

Study Arms (2)

Diet 1

ACTIVE COMPARATOR

Patients randomized to this arm will receive both written and face-to-face advice about how the components of Diet 1 can be used to control their IBS symptoms.

Other: Dietary intervention

Diet 2

ACTIVE COMPARATOR

Patients randomized to this arm will receive both written and face-to-face advice about how the components of Diet 2 can be used to control their IBS symptoms.

Other: Dietary intervention

Interventions

Dietary intervention OTHER

After a 14 day screening period, subjects will be randomized to 1 of 2 diets to treat their IBS symptoms. They will receive dietary instruction and are expected to remain on this diet for 4 weeks.

Diet 1; Diet 2

Eligibility Criteria

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

You may qualify if:

• Meet Rome III criteria for IBS as assessed by a gastroenterologist:
• Fulfill the Rome III stool consistency criteria for IBS -D
• Willingness to maintain a stable dosage of IBS medications during the pretreatment baseline period, including tricyclic antidepressants; "rescue" medications permitted (ie Loperamide 2mg up to 4 times per day prn diarrhea)
• Ability to provide written informed consent for study participation
• Capable of independently completing all requirements of the study including returning for required visits
• Documentation of normal colonoscopy with colon biopsies within five years
• Documentation of normal TSH, CBC, electrolyte panel
• Negative evaluation for celiac disease either with normal TTG, EMA, and/or duodenal biopsy.

You may not qualify if:

• Unable to understand or provide written informed consent
• Pregnancy
• IBS with constipation or mixed subtype
• Comorbid medical problems that may affect gastrointestinal transit or motility:
• Inflammatory bowel disease
• Extraintestinal disease known to affect the gastrointestinal system (ie, scleroderma, unstable thyroid disease, diabetes mellitus, etc.)
• Severe renal or hepatic disease
• Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery
• Previous treatment with some diets for IBS
• Concurrent medications not permitted including probiotics, antibiotics, and narcotics
• Active participation in another form of dietary therapy
• Patients who have undergone surgery to the GI tract except appendectomy or cholecystectomy if performed more than six months prior to enrollment.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Eswaran S, Chey WD, Jackson K, Pillai S, Chey SW, Han-Markey T. A Diet Low in Fermentable Oligo-, Di-, and Monosaccharides and Polyols Improves Quality of Life and Reduces Activity Impairment in Patients With Irritable Bowel Syndrome and Diarrhea. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1890-1899.e3. doi: 10.1016/j.cgh.2017.06.044. Epub 2017 Jun 28.

  PMID: 28668539 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea; Abdominal Pain

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Shanti L Eswaran, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 20, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

US (2)