ConstipationNCT05037565
Effectiveness of Partially Hydrolyzed Guar Gum in Improving Fecal Characteristics in Long Term Care Facility Residents
A study testing Partially hydrolyzed guar gum in people with Constipation, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Partially hydrolyzed guar gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- Jan 2022to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Queen Mary Hospital and Fung Yiu King Hospital, Hong Kong West Cluster, Hospital Authority
Hong Kong
Tuen Ching Chan, MD, 85266816077, tuenching@yahoo.com.hk
Tuen Ching Chan, MD
About this study
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.
Read the 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
- Conditions
- Constipation
- Being tested
- Partially hydrolyzed guar gum
- Keywords
- constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially hydrolyzed guar gumDietary supplement
Also called PHGG
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | One group receive PHGG following study protocol (treatment group). Receives: Dietary Supplement: Partially hydrolyzed guar gum |
| Control group | No intervention | This group will not receive PHGG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline stool characteristics at 4 weeks
Secondary outcomes (1)
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".
Measured: Change in frequency of laxative use by participant per week from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study startJan 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chan Tuen Ching, The University of Hong Kong
- Investigators
- Tuen Ching Chan, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037565
- Sponsor's protocol ID
- UW 20-521
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16413751Niv 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.
PubMed 26855665Polymeros 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.
PubMed 24711073Patrick 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.
PubMed 9710664Yasukawa 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.
PubMed 31509971Finley 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.
PubMed 23347282Chan 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.
PubMed 35297467
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Partially Hydrolyzed Guar Gum in Improving Fecal Characteristics in Long Term Care Facility Residents
- ClinicalTrials.gov ID
- NCT05037565
- Acronym / sponsor ID
- UW 20-521
- Conditions
- Constipation
- Keywords
- constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Dietary Supplement: Partially hydrolyzed guar gumOne group receive PHGG following study protocol (treatment group). |
| Control group | No intervention | –This group will not receive PHGG |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partially hydrolyzed guar gumAlso: PHGGPartially 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. | Dietary supplement | Treatment group |
Primary outcome
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).
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 16413751Giannini 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.
- Background: PubMed 26855665Niv 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.
- Background: PubMed 24711073Polymeros 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.
- Background: PubMed 9710664Patrick 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.
- Background: PubMed 31509971Yasukawa 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.
- Background: PubMed 23347282Finley 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.
- Derived from this study: PubMed 35297467Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuen Ching Chan, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partially hydrolyzed guar gum in people with Constipation, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuen Ching Chan, MD (28556133, ctc029@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fecal characteristics (assessed by Bristol Stool Scale) from baseline at 4 weeks (time frame: Change from baseline stool characteristics at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05037565, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.