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

Phase 4

• Conditions: IBS
• Interventions: Dietary Supplement: PHGG; Dietary Supplement: Maltodextrin

• Registration Number: NCT01779765
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-27
• Study First Posted: 2013-01-30
• Last Update Submitted: 2014-03-26
• Last Update Posted: 2014-03-27
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PHGG	PHGG	2.5gr per day for the first week and then 5gr per day for 11 weeks.
Maltodextrin	Maltodextrin	2.5gr per day for the first week and then 5gr per day for 11 weeks.

Primary Outcome Measures

Name	Time	Method
Improvement in IBS score.	2 years	IBS scoring - Francis severity IBS score.

Secondary Outcome Measures

Name	Time	Method
Quality questionnaire	2 years	Quality of life - by the IBS - quality of life questionnaire - Drossman Patrick.

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel