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Status unknownNCT02327780Updated Dec 30, 2014

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

An interventional study of FODMAP diet in Irritable Bowel Syndrome, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 77 Years. Per ClinicalTrials.gov, last updated 2014-12-30.

Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 77 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's planned enrollment of 40 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 77 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Other
    FODMAP diet

    participants will be put on a low FODMAP diet.

    Other: FODMAP diet

Interventions

  • OtherFODMAP diet
06

What researchers measure

Primary outcomes

  1. Irritable Bowel Syndrome (IBS) severity score

    Time frame: 9 weeks

  2. IBS quality of life score

    Time frame: 9 weeks

07

Study locations

1 site
  • Clinical Nutrition Unit, Sourasky Medical Center
    Tel Aviv, 64239, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02327780
Lead sponsor
Tel-Aviv Sourasky Medical Center
Responsible party
Sponsor
First posted
Dec 30, 2014
Start date
Jan 2015
Primary completion
Jan 2016 (estimated)
Completion
Mar 2016 (estimated)
Last update
Dec 30, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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