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

Primary Purpose

IBS

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
PHGG
Maltodextrin
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBS focused on measuring IBS, Diarrhea, Constipation, Fibers

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tel Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PHGG

Maltodextrin

Arm Description

2.5gr per day for the first week and then 5gr per day for 11 weeks.

2.5gr per day for the first week and then 5gr per day for 11 weeks.

Outcomes

Primary Outcome Measures

Improvement in IBS score.
IBS scoring - Francis severity IBS score.

Secondary Outcome Measures

Quality questionnaire
Quality of life - by the IBS - quality of life questionnaire - Drossman Patrick.

Full Information

First Posted
January 10, 2013
Last Updated
March 26, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01779765
Brief Title
The Efficacy of Hydrolyzed Guar Gum ( PHGG) in the Treatment of Patients With Irritable Bowel Syndrome (IBS)
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS
Keywords
IBS, Diarrhea, Constipation, Fibers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PHGG
Arm Type
Experimental
Arm Description
2.5gr per day for the first week and then 5gr per day for 11 weeks.
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
2.5gr per day for the first week and then 5gr per day for 11 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
PHGG
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Primary Outcome Measure Information:
Title
Improvement in IBS score.
Description
IBS scoring - Francis severity IBS score.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality questionnaire
Description
Quality of life - by the IBS - quality of life questionnaire - Drossman Patrick.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nachum Vaisman, MD
Phone
972-3-6974807
Email
vaisman@tasmc.health.gov.il
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nachum Vaisman, MD
Phone
972-3-6974807
Email
vaisman@tasmc.health.gov.il

12. IPD Sharing Statement

Citations:
PubMed Identifier
11053260
Citation
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.
Results Reference
background
PubMed Identifier
14645642
Citation
Mertz HR. Irritable bowel syndrome. N Engl J Med. 2003 Nov 27;349(22):2136-46. doi: 10.1056/NEJMra035579. No abstract available.
Results Reference
background
PubMed Identifier
12184518
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. doi: 10.1023/a:1016419906546.
Results Reference
background
PubMed Identifier
26855665
Citation
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.
Results Reference
derived

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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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