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

This study is currently recruiting participants.
Verified January 2013 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01779765
First received: January 10, 2013
Last updated: January 27, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
IBS
 Dietary Supplement: PHGG
Dietary Supplement: Maltodextrin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Efficacy of Hydrolyzed Guar Gum ( PHGG) in the Treatment of Patients With Irritable Bowel Syndrome- a Double Blind, Placebo - Controlled, Randomized Study

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Improvement in IBS score. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    IBS scoring - Francis severity IBS score.


Secondary Outcome Measures:
  • Quality questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Quality of life - by the IBS - quality of life questionnaire - Drossman Patrick.


Estimated Enrollment: 130
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779765

Contacts
Contact: Nachum Vaisman, MD 972-3-6974807 vaisman@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Nachum Vaisman, MD     972-3-6974807     vaisman@tasmc.health.gov.il    
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

Publications:

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01779765     History of Changes
Other Study ID Numbers: TASMC-12-NV-242-CTIL
Study First Received: January 10, 2013
Last Updated: January 27, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
IBS
Diarrhea
Constipation
Fibers

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013