Effectiveness of Partially Hydrolyzed Guar Gum in Improving Fecal Characteristics in Long Term Care Facility Residents
Primary Purpose
Constipation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Partially hydrolyzed guar gum
Sponsored by
About this trial
This is an interventional prevention trial for Constipation focused on measuring constipation
Eligibility 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
Sites / Locations
- Queen Mary Hospital and Fung Yiu King Hospital, Hong Kong West Cluster, Hospital AuthorityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control group
Arm Description
One group receive PHGG following study protocol (treatment group).
This group will not receive PHGG
Outcomes
Primary Outcome Measures
Change in Fecal characteristics (assessed by Bristol Stool Scale) from baseline 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
Change in frequency of laxative use by participants per week
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".
Full Information
NCT ID
NCT05037565
First Posted
August 27, 2021
Last Updated
September 27, 2021
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05037565
Brief Title
Effectiveness of Partially Hydrolyzed Guar Gum in Improving Fecal Characteristics in Long Term Care Facility Residents
Official Title
Effectiveness of Partially Hydrolyzed Guar Gum in Improving Fecal Characteristics in Long Term Care Facility Residents
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
One group receive PHGG following study protocol (treatment group).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will not receive PHGG
Intervention Type
Dietary Supplement
Intervention Name(s)
Partially hydrolyzed guar gum
Other Intervention Name(s)
PHGG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Fecal characteristics (assessed by Bristol Stool Scale) from baseline at 4 weeks
Description
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).
Time Frame
Change from baseline stool characteristics at 4 weeks
Secondary Outcome Measure Information:
Title
Change in frequency of laxative use by participants per week
Description
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".
Time Frame
Change in frequency of laxative use by participant per week from baseline at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuen Ching Chan, MD
Phone
28556133
Email
ctc029@ha.org.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuen Ching Chan, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital and Fung Yiu King Hospital, Hong Kong West Cluster, Hospital Authority
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuen Ching Chan, MD
Phone
85266816077
Email
tuenching@yahoo.com.hk
First Name & Middle Initial & Last Name & Degree
Tuen Ching Chan, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16413751
Citation
Giannini EG, Mansi C, Dulbecco P, Savarino V. Role of partially hydrolyzed guar gum in the treatment of irritable bowel syndrome. Nutrition. 2006 Mar;22(3):334-42. doi: 10.1016/j.nut.2005.10.003. Epub 2006 Jan 18.
Results Reference
background
PubMed Identifier
26855665
Citation
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.
Results Reference
background
PubMed Identifier
24711073
Citation
Polymeros D, Beintaris I, Gaglia A, Karamanolis G, Papanikolaou IS, Dimitriadis G, Triantafyllou K. Partially hydrolyzed guar gum accelerates colonic transit time and improves symptoms in adults with chronic constipation. Dig Dis Sci. 2014 Sep;59(9):2207-14. doi: 10.1007/s10620-014-3135-1. Epub 2014 Apr 8.
Results Reference
background
PubMed Identifier
9710664
Citation
Patrick PG, Gohman SM, Marx SC, DeLegge MH, Greenberg NA. Effect of supplements of partially hydrolyzed guar gum on the occurrence of constipation and use of laxative agents. J Am Diet Assoc. 1998 Aug;98(8):912-4. doi: 10.1016/S0002-8223(98)00210-7. No abstract available.
Results Reference
background
PubMed Identifier
31509971
Citation
Yasukawa Z, Inoue R, Ozeki M, Okubo T, Takagi T, Honda A, Naito Y. Effect of Repeated Consumption of Partially Hydrolyzed Guar Gum on Fecal Characteristics and Gut Microbiota: A Randomized, Double-Blind, Placebo-Controlled, and Parallel-Group Clinical Trial. Nutrients. 2019 Sep 10;11(9):2170. doi: 10.3390/nu11092170.
Results Reference
background
PubMed Identifier
23347282
Citation
Finley JW, Soto-Vaca A, Heimbach J, Rao TP, Juneja LR, Slavin J, Fahey GC. Safety assessment and caloric value of partially hydrolyzed guar gum. J Agric Food Chem. 2013 Feb 27;61(8):1756-71. doi: 10.1021/jf304910k. Epub 2013 Feb 12.
Results Reference
background
PubMed Identifier
35297467
Citation
Chan TC, Yu VMW, Luk JKH, Chu LW, Yuen JKY, Chan FHW. Effectiveness of Partially Hydrolyzed Guar Gum in Reducing Constipation in Long Term Care Facility Residents: A Randomized Single-Blinded Placebo-Controlled Trial. J Nutr Health Aging. 2022;26(3):247-251. doi: 10.1007/s12603-022-1747-2.
Results Reference
derived
Learn more about this trial
Effectiveness of Partially Hydrolyzed Guar Gum in Improving Fecal Characteristics in Long Term Care Facility Residents
We'll reach out to this number within 24 hrs