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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02327780
• Other study ID #: 407-14-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: December 24, 2014
• Last updated: December 29, 2014
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: December 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 77 Years

Eligibility

Inclusion Criteria:

1. Fulfillment of the Rome III criteria for IBS.

2. Aged 18-77 years at the time of screening.

3. Provision of written informed consent.

4. Commitment of availability throughout the 10 week study period.

5. 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.

Exclusion Criteria:

1. Major abdominal surgery in the past.

2. The presence of any active (organic) GI disease.

3. Past or present major medical or psychiatric illness.

4. Any concomitant disease.

5. Alarming symptoms (rectal bleeding, weight loss, etc.)

6. Pregnancy.

7. Family history of colorectal carcinoma or IBD, under the age of 50.

8. Abnormal laboratory studies (blood biochemistry, liver enzymes, complete blood count), abnormal thyroid function.

9. Non-adjusted diet in the case of lactose or gluten intolerance.

10. Recent travel to regions with endemic parasitic diseases.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• FODMAP diet

Locations

Country	Name	City	State
Israel	Clinical Nutrition Unit, Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irritable Bowel Syndrome (IBS) severity score		9 weeks	No
Primary	IBS quality of life score		9 weeks	No