Clinical trial NCT01779765: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: IBS
Keywords: IBS
Diarrhea
Constipation
Fibers
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-01-30
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Improvement in IBS score.
timeFrame: 2 years
Secondary outcomes:
measure: Quality questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References:
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.
citation: Mertz HR. Irritable bowel syndrome. N Engl J Med. 2003 Nov 27;349(22):2136-46. doi: 10.1056/NEJMra035579. No abstract available.
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.
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.