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

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ClinicalTrials.gov Identifier: NCT01779765
Recruitment Status : Unknown
Verified January 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : January 30, 2013
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
IBS Dietary Supplement: PHGG Dietary Supplement: Maltodextrin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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
Study Start Date : January 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

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



Primary Outcome Measures :
  1. Improvement in IBS score. [ Time Frame: 2 years ]
    IBS scoring - Francis severity IBS score.


Secondary Outcome Measures :
  1. Quality questionnaire [ Time Frame: 2 years ]
    Quality of life - by the IBS - quality of life questionnaire - Drossman Patrick.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01779765     History of Changes
Other Study ID Numbers: TASMC-12-NV-242-CTIL
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: January 2013

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