Effectiveness of Partially Hydrolyzed Guar Gum in Improving Fecal Characteristics in Long Term Care Facility Residents

September 27, 2021 updated by: Dr. Chan Tuen Ching, The University of Hong Kong
Partially hydrolyzed guar gum (PHGG) is a vegetal, water soluble, non-viscous, non-gelling dietary fiber that is derived from guar gum, a water-soluble, viscous, gelling polysaccharide found in the seeds of Cyamopsis tetragonolobus. PHGG is food for special medical purpose and available over-the-counter. It is as effective as lactulose treatment in relieving constipation associated abdominal pain in children. Up-to-date, there is no randomized study regarding the effectiveness of PHGG in reducing constipation in long term care facility residents, the investigator therefore would like to perform a prospective, randomized study to assess its effectiveness in long term care facility residents to improve fecal characteristics and its effect on use of laxative agents.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, single blinded, parallel-group trial for the residents in long term care facilities covered by Community Geriatric Assessment Team of Queen Mary Hospital and Fung Yiu King Hospital. The investigator aim to recruit 52 subjects from those long term care facilities.

Subject fulfilling the inclusion criteria will be screened from the Community Geriatric Assessment Team (CGAT) of Fung Yiu King Hospital by the investigators. Study information will be explained to subject in detail and consent form (in Chinese) will be given to subject. Before commencing, subjects will be allowed to have one week to consider joining the study.

After informed consent, subjects will be randomly assigned into 2 groups. One group receive PHGG following study protocol (treatment group). Another group will be control group, no PHGG will be given. For treatment group, subjects will take 5g PHGG per day (which equals 4.2g dietary fiber) through mixing with 20ml water during treatment period. Since after mixing with PHGG, the water remains colorless and odorless, control group will also be given 20ml water by long term care facility staff as a blinding process to participant.

The study consist of two periods: a 2-week run-in period and a 4-week treatment period. During run-in period, patient's demographic characteristics will be recorded. Eligibility of patients to proceed to the treatment period will be determined, according to their baseline symptoms stool log. Stool frequency, stool characteristics (according to Bristol stool scale ranging from 1: hard stool to 7: liquid stool) and use of laxative medication will be recorded through a record diary given to subjects. During treatment period, both group of subjects need to record stool frequency, stool characteristics and use of laxative medication. Any adverse reaction will be recorded. Satisfaction of subjects towards PHGG will be assessed by questionnaire with quantification through Likert scale. Subjects will be instructed to maintain their usual daily activities including exercise, food habits, and medication consumption.

Outcome measures:

Primary outcome Fecal frequency (assessed by recording defecation times/day) Fecal characteristics (assessed by Bristol Stool Scale)

Secondary outcome Use of laxative agents per day

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • Queen Mary Hospital and Fung Yiu King Hospital, Hong Kong West Cluster, Hospital Authority
        • Contact:
        • Principal Investigator:
          • Tuen Ching Chan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Long term care facility residents at the age of 65 or above.
  • All participants give written informed consent.
  • Participants must be available to complete the study and comply with study procedures

Exclusion Criteria:

  • Previous major surgery of the abdomen
  • Use of PHGG in the 4 months prior to the study initiation
  • Chronic constipation due to primary organic disorder of the large bowel e.g. neoplasia, post-radiation or inflammatory strictures
  • On regular laxative treatment
  • Patient with severe hypothyroidism
  • Patients suffering from disease of the spine cord
  • Subject receiving antibiotics within 3 month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
One group receive PHGG following study protocol (treatment group).
Dietary supplement: Partially hydrolyzed guar gum
Partially hydrolyzed guar gum (PHGG) is a vegetal, water soluble, non-viscous, non-gelling dietary fiber that is derived from guar gum, a water-soluble, viscous, gelling polysaccharide found in the seeds of Cyamopsis tetragonolobus. PHGG is available over the counter as a dietary supplement as fiber.
Other Names:
  • PHGG
No Intervention: Control group
This group will not receive PHGG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fecal characteristics (assessed by Bristol Stool Scale) from baseline at 4 weeks
Time Frame: Change from baseline stool characteristics at 4 weeks

Fecal characteristics will be assessed at baseline and at 4 weeks after intervention by Bristol Stool scale. The change of stool characteristics from baseline at 4 weeks will be measured.

Bristol stool scale range from 1 (hard stool) to 7 (liquid stool).
Change from baseline stool characteristics at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in frequency of laxative use by participants per week
Time Frame: Change in frequency of laxative use by participant per week from baseline at 4 weeks

Frequency of laxative use will be recorded at baseline and 4 weeks after intervention. The change in frequency of laxative use by participants will be measured.

Frequency of laxative use will be quantified as "units per week" Senokot, lactulose and dulcolax are main laxative used by long term care facility residents.

One unit of laxative is "7.5mg of senokot", "10ml lactulose" or "10mg of dulcolax".
Change in frequency of laxative use by participant per week from baseline at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Tuen Ching Chan, MD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 20-521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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