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
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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UNKNOWN
PHASE4
130 participants
INTERVENTIONAL
2013-01-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PHGG
2.5gr per day for the first week and then 5gr per day for 11 weeks.
PHGG
Maltodextrin
2.5gr per day for the first week and then 5gr per day for 11 weeks.
Maltodextrin
Interventions
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PHGG
Maltodextrin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Locations
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Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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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.
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.
Other Identifiers
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TASMC-12-NV-242-CTIL
Identifier Type: -
Identifier Source: org_study_id
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