The Effectivness of FODMAP Diet in Israel in Relieving Symptoms of Patients With Irritable Bowel Syndrome

NCT02327780 | Unknown

• 1 other identifier: 407-14-TLV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of IBS is very problematic. Despite the wide range of pharmacological and non-pharmacological therapies, there is no universally accepted approach. In recent years, the low FODMAP diet has been developed, a dietary approach that aims to relieve the symptoms of IBS. FODMAPs (Fermentable Oligosaccharides, Di-saccharides, Mono-saccharides and Polyols) are a group of dietary sugars that may be poorly absorbed in the small intestine and fermented by bacteria to produce gas. Ingestion of FODMAPs may also result in alterations in fluid content in the colon and trigger functional gut symptoms in some individuals. This study aims to examine the effectiveness of the FODMAP diet in Israel in improving symptoms of IBS compared to the standard dietary advice.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Irritable Bowel Syndrome (IBS) severity score

  9 weeks

• IBS quality of life score

  9 weeks

Study Arms (1)

FODMAP diet

OTHER

participants will be put on a low FODMAP diet.

Other: FODMAP diet

Interventions

FODMAP diet OTHER

FODMAP diet

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfillment of the Rome III criteria for IBS.
• Aged 18-77 years at the time of screening.
• Provision of written informed consent.
• Commitment of availability throughout the 10 week study period.
• Availability of at least one GI imaging study during the last 5 years (colonoscopy, sigmoidosopy, abdominal ultrasonography, barium enema) for subjects older than 50 years.

You may not qualify if:

• Major abdominal surgery in the past.
• The presence of any active (organic) GI disease.
• Past or present major medical or psychiatric illness.
• Any concomitant disease.
• Alarming symptoms (rectal bleeding, weight loss, etc.)
• Pregnancy.
• Family history of colorectal carcinoma or IBD, under the age of 50.
• Abnormal laboratory studies (blood biochemistry, liver enzymes, complete blood count), abnormal thyroid function.
• Non-adjusted diet in the case of lactose or gluten intolerance.
• Recent travel to regions with endemic parasitic diseases.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Clinical Nutrition Unit, Sourasky Medical Center

Tel Aviv, 64239, Israel

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: December 30, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

IL (1)