The Efficacy of Hydrolyzed Guar Gum ( PHGG) in the Treatment of Patients With Irritable Bowel Syndrome (IBS)

March 26, 2014 updated by: Tel-Aviv Sourasky Medical Center

The Efficacy of Hydrolyzed Guar Gum ( PHGG) in the Treatment of Patients With Irritable Bowel Syndrome- a Double Blind, Placebo - Controlled, Randomized Study

This study objective is to assess the short and long term effects of partially hydrolyzed guar gum (PHGG) administration on clinical symptoms of IBS and quality of life of these patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fulfillment of the Rome III criteria for IBS.
  • Aged 20-68 years at the time of screening.
  • Provision of written informed consent.
  • Commitment of availability throughout the 6 months study period.

Exclusion Criteria:

  • 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 inflammatory bowel disease (IBD).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PHGG
2.5gr per day for the first week and then 5gr per day for 11 weeks.
Dietary supplement: PHGG
Placebo Comparator: Maltodextrin
2.5gr per day for the first week and then 5gr per day for 11 weeks.
Dietary supplement: Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in IBS score.
Time Frame: 2 years
IBS scoring - Francis severity IBS score.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality questionnaire
Time Frame: 2 years
Quality of life - by the IBS - quality of life questionnaire - Drossman Patrick.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

January 27, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Estimate)

March 27, 2014

Last Update Submitted That Met QC Criteria

March 26, 2014

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-12-NV-242-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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