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

NCT05037565 | Unknown DMC

• 1 other identifier: UW 20-521
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

constipation

Outcome Measures

Primary Outcomes (1)

• 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).

  Change from baseline stool characteristics at 4 weeks

Secondary Outcomes (1)

• Change in frequency of laxative use by participants per week

  Change in frequency of laxative use by participant per week from baseline at 4 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

One group receive PHGG following study protocol (treatment group).

Dietary Supplement: Partially hydrolyzed guar gum

Control group

NO INTERVENTION

This group will not receive PHGG

Interventions

Partially hydrolyzed guar gum DIETARY_SUPPLEMENT

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.

Also known as: PHGG

Treatment group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital and Fung Yiu King Hospital, Hong Kong West Cluster, Hospital Authority

Hong Kong, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 16413751 BACKGROUND

• 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: 26855665 BACKGROUND

• 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.

  PMID: 24711073 BACKGROUND

• 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.

  PMID: 9710664 BACKGROUND

• 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.

  PMID: 31509971 BACKGROUND

• 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.

  PMID: 23347282 BACKGROUND

• 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.

  PMID: 35297467 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tuen Ching Chan, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuen Ching Chan, MD

CONTACT

28556133; ctc029@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Associate Professor

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 8, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)