Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

NCT02828384 | Completed Phase 2

• 1 other identifier: 00079064
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP diet in FI patients is needed. Aims:

1. 1.Compare the treatment response with a low FODMAP vs. psyllium based on number of episodes in patients with FI.
2. 2.Compare the efficacy of a low FODMAP diet vs. psyllium in patients with FI on pre-specified clinical and quality of life endpoints.

Conditions

Fecal Incontinence

Keywords

fodmap diet

Outcome Measures

Primary Outcomes (1)

• Change in number of FI episodes from baseline to week 4

  Will compare baseline number of FI episodes to number of FI episodes at week 4

  4 weeks from baseline

Secondary Outcomes (7)

• number of people responding with decreased score in stool consistency

  4 week span from baseline

• number of people responding with reduction in stool frequency

  4 weeks from baseline

• Change in stool wet weight

  4 weeks from baseline

• Change in Fecal incontinence severity index (FISI)

  4 weeks from baseline

• Change in Fecal incontinence quality of life measure (FIqol)

  4 weeks from baseline

Study Arms (2)

low fodmap diet

ACTIVE COMPARATOR

Subjects receive formalized teaching in low fodmap diet by a dietician

Other: low fodmap diet

psyllium

ACTIVE COMPARATOR

subjects receive 7.1 g of psyllium daily

Dietary Supplement: Psyllium

Interventions

low fodmap diet OTHER

dietary teaching

low fodmap diet

Psyllium DIETARY_SUPPLEMENT

7.1g of psyllium daily

psyllium

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experience at least 1 episode/week of unintentional loss of stool associated with diarrhea/loose stool (Bristol stool scale of 5 or greater).
• Subjects aged 18 and older meeting the Rome III criteria for Functional Fecal incontinence diagnostic criteria:
• Recurrent uncontrolled passage of fecal material in an individual and one or more of the following:
• Abnormal functioning of normally innervated and structurally intact muscles
• Minor abnormalities of sphincter structure and/or innervation
• Normal or disordered bowel habits, (i.e., diarrhea) Criteria fulfilled for the last 3 months

You may not qualify if:

• Abnormal innervation caused by lesion(s) within the brain (e.g., dementia), spinal cord, or sacral nerve roots, or mixed lesions (e.g., multiple sclerosis), or as part of a generalized peripheral or autonomic neuropathy
• Anal sphincter abnormalities associated with a multisystem disease (e.g., scleroderma)
• Structural or neurogenic abnormalities believed to be the major or primary cause of fecal incontinence
• Have cognitive dysfunction or unable to understand or provide written informed consent
• Pregnancy
• FI with solid stool only
• Comorbid medical problems that may affect gastrointestinal transit or motility: Inflammatory bowel disease, Extraintestinal disease known to affect the gastrointestinal system (i.e., scleroderma, unstable thyroid disease, etc.),Severe renal or hepatic disease
• Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery.
• Previous treatment with low FODMAP diet.
• Concurrent medications not permitted including probiotics, antibiotics, and narcotics.
• Active participation in another form of dietary therapy.

Sponsors & Collaborators

• University of Michigan: lead
• The Rome Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Menees SB, Jackson K, Baker JR, Fenner DE, Eswaran S, Nojkov B, Saad R, Lee AA, Chey WD. A Randomized Pilot Study to Compare the Effectiveness of a Low FODMAP Diet vs Psyllium in Patients With Fecal Incontinence and Loose Stools. Clin Transl Gastroenterol. 2022 Feb 19;13(3):e00454. doi: 10.14309/ctg.0000000000000454.

  PMID: 35060943 DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Interventions

FODMAP Diet; Psyllium

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Stacy B Menees, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: July 11, 2016
• Study Start: October 2, 2014
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (1)