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

IBS Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01779765
• Other study ID #: TASMC-12-NV-242-CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: January 10, 2013
• Last updated: March 26, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2013
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nachum Vaisman, MD
• Phone: 972-3-6974807
• Email: vaisman[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• IBS
• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• PHGG

• Maltodextrin

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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:ii1-19. — View Citation

Mertz HR. Irritable bowel syndrome. N Engl J Med. 2003 Nov 27;349(22):2136-46. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in IBS score.	IBS scoring - Francis severity IBS score.	2 years	No
Secondary	Quality questionnaire	Quality of life - by the IBS - quality of life questionnaire - Drossman Patrick.	2 years	No