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.

Study Overview

• Status: Unknown
• Conditions: IBS
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: PHGG

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nachum Vaisman, MD; Phone Number: 972-3-6974807; Email: vaisman@tasmc.health.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Tel Aviv Sourasky Medical Center
    • Contact: Nachum Vaisman, MD; Phone Number: 972-3-6974807; Email: vaisman@tasmc.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 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

How is the study designed?

Design Details

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

Number of Arms

2

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.	IBS scoring - Francis severity IBS score.	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Publications and helpful links

General Publications

• Jones J, Boorman J, Cann P, Forbes A, Gomborone J, Heaton K, Hungin P, Kumar D, Libby G, Spiller R, Read N, Silk D, Whorwell P. British Society of Gastroenterology guidelines for the management of the irritable bowel syndrome. Gut. 2000 Nov;47 Suppl 2(Suppl 2):ii1-19. doi: 10.1136/gut.47.suppl_2.ii1. No abstract available.
• Mertz HR. Irritable bowel syndrome. N Engl J Med. 2003 Nov 27;349(22):2136-46. doi: 10.1056/NEJMra035579. No abstract available.
• Parisi GC, Zilli M, Miani MP, Carrara M, Bottona E, Verdianelli G, Battaglia G, Desideri S, Faedo A, Marzolino C, Tonon A, Ermani M, Leandro G. High-fiber diet supplementation in patients with irritable bowel syndrome (IBS): a multicenter, randomized, open trial comparison between wheat bran diet and partially hydrolyzed guar gum (PHGG). Dig Dis Sci. 2002 Aug;47(8):1697-704. doi: 10.1023/a:1016419906546.
• Niv E, Halak A, Tiommny E, Yanai H, Strul H, Naftali T, Vaisman N. Randomized clinical study: Partially hydrolyzed guar gum (PHGG) versus placebo in the treatment of patients with irritable bowel syndrome. Nutr Metab (Lond). 2016 Feb 6;13:10. doi: 10.1186/s12986-016-0070-5. eCollection 2016.

Study record dates

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: Diarrhea; Constipation; IBS; Fibers
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: TASMC-12-NV-242-CTIL