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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

January 10, 2013
January 27, 2013
January 2013
June 2014   (final data collection date for primary outcome measure)
Improvement in IBS score. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
IBS scoring - Francis severity IBS score.
Same as current
Complete list of historical versions of study NCT01779765 on ClinicalTrials.gov Archive Site
Quality questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Quality of life - by the IBS - quality of life questionnaire - Drossman Patrick.
Same as current
Not Provided
Not Provided
 
The Efficacy of Hydrolyzed Guar Gum ( PHGG) in the Treatment of Patients With Irritable Bowel Syndrome (IBS)
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
IBS
  • Dietary Supplement: PHGG
  • Dietary Supplement: Maltodextrin
  • Experimental: PHGG
    2.5gr per day for the first week and then 5gr per day for 11 weeks.
    Intervention: Dietary Supplement: PHGG
  • Placebo Comparator: Maltodextrin
    2.5gr per day for the first week and then 5gr per day for 11 weeks.
    Intervention: Dietary Supplement: Maltodextrin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
20 Years to 68 Years
No
Contact: Nachum Vaisman, MD 972-3-6974807 vaisman@tasmc.health.gov.il
Israel
 
NCT01779765
TASMC-12-NV-242-CTIL
No
Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP