NCT01779765

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 27, 2014

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

January 10, 2013

Last Update Submit

March 26, 2014

Conditions

IBS

Keywords

IBSDiarrheaConstipationFibers

Outcome Measures

Primary Outcomes (1)

  • Improvement in IBS score.

    IBS scoring - Francis severity IBS score.

    2 years

Secondary Outcomes (1)

  • Quality questionnaire

    2 years

Study Arms (2)

PHGG

EXPERIMENTAL

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

Dietary Supplement: PHGG

Maltodextrin

PLACEBO COMPARATOR

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

Dietary Supplement: Maltodextrin

Interventions

PHGGDIETARY_SUPPLEMENT
PHGG
MaltodextrinDIETARY_SUPPLEMENT
Maltodextrin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Related Publications (4)

  • 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.

    PMID: 11053260BACKGROUND

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

    PMID: 14645642BACKGROUND

  • 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.

    PMID: 12184518BACKGROUND

  • 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.

    PMID: 26855665DERIVED

MeSH Terms

Conditions

DiarrheaConstipation

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Nachum Vaisman, MD

CONTACT

972-3-6974807vaisman@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 30, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 27, 2014

Record last verified: 2013-01

Locations

IL(1)