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

NCT ID: NCT01779765

Last Updated: 2014-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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IBS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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PHGG

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

Group Type EXPERIMENTAL

PHGG

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

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

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Interventions

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PHGG

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Nachum Vaisman, MD

Role: CONTACT

972-3-6974807

Facility Contacts

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Nachum Vaisman, MD

Role: primary

972-3-6974807

References

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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.

Reference Type BACKGROUND
PMID: 11053260 (View on PubMed)

Mertz HR. Irritable bowel syndrome. N Engl J Med. 2003 Nov 27;349(22):2136-46. doi: 10.1056/NEJMra035579. No abstract available.

Reference Type BACKGROUND
PMID: 14645642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12184518 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26855665 (View on PubMed)

Other Identifiers

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TASMC-12-NV-242-CTIL

Identifier Type: -

Identifier Source: org_study_id

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