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

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ClinicalTrials.gov Identifier: NCT05037565
Recruitment Status : Recruiting
First Posted : September 8, 2021
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Chan Tuen Ching, The University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Constipation Dietary Supplement: Partially hydrolyzed guar gum Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effectiveness of Partially Hydrolyzed Guar Gum in Improving Fecal Characteristics in Long Term Care Facility Residents
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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 Name: PHGG

No Intervention: Control group
This group will not receive PHGG



Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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".




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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037565


Contacts
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Contact: Tuen Ching Chan, MD 28556133 ctc029@ha.org.hk

Locations
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China
Queen Mary Hospital and Fung Yiu King Hospital, Hong Kong West Cluster, Hospital Authority Recruiting
Hong Kong, China
Contact: Tuen Ching Chan, MD    85266816077    tuenching@yahoo.com.hk   
Principal Investigator: Tuen Ching Chan, MD         
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Tuen Ching Chan, MD The University of Hong Kong
Publications:

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Responsible Party: Dr. Chan Tuen Ching, Honorary Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT05037565    
Other Study ID Numbers: UW 20-521
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Dr. Chan Tuen Ching, The University of Hong Kong:
constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive