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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 4

Conditions: IBS

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: PHGG

Study type: Interventional

Funder types: Other

Identifiers

NCT01779765

TASMC-12-NV-242-CTIL

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups, including a placebo group

PHGG

Experimental group

Description:

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

Treatment:

Dietary Supplement: PHGG

Maltodextrin

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Maltodextrin