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NCT04678349 Clinical Trial

The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy

Rectal Cancer Clinical Trial

Official title:
The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04678349
Other study ID # NMRR-19-3119-51323
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date November 29, 2021

Study information
Verified date November 2022
Source Universiti Putra Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

this is a cross sectional intervention study to investigate the role of partial hydrolyzed guar gum in high stoma output management among cancer patients with ileostomy. This study hypotheses there is improvement in stoma output in PHGG if compare with control. There are two groups of subjects in this study. Conventional group (CG) will include retrospective historical data (those subjects with post-operative ileostomy) from Jan 2016 to June 2019. Intervention group (PHGG) will be subjects with ileostomy which involves prospective intervention by giving partial hydrolyzed guar gum upon start orally. Data on stoma output (volume & consistency), length of hospital stay, readmission within 30-days discharged and dietary intake will be recorded in data collection form.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date November 29, 2021
Est. primary completion date September 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Cancer patients with ileostomy - At least 18 years of age - Malaysian Exclusion Criteria: - Not cancer patients with ileostomy - Patients who participate in other study at the same time - Vulnerable subjects - Palliative patients - Patient has fistula

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• PHGG
Subjects will be given 4 scoops (40g) PHGG, which provide 160kcal, 0.24g protein, 30.4g soluble fibre, 40g carbohydrate and 0g sugar, once allowed orally.
Other:
• conventional care
follow low fibre diet and anti-diarrhea drugs

Locations
Country Name City State
Malaysia National Cancer Institute Putrajaya

Sponsors (2)
Lead Sponsor Collaborator
Universiti Putra Malaysia National Cancer Institute, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary ileostomy stoma output consistency (bristrol stool chart; range 1-7; 1 hard while 7 watery) up to 1 month
Primary ileostomy stoma output volume (ml) up to 1 month
Secondary Length of hospital stay days of hospital stays up to 1 month
Secondary Readmission within 30-days discharged readmit to ward due to complications after discharge up to 1 month
Secondary Dietary intake energy (kcal/day) up to 1 month
Secondary dietary intake protein intake (g/day) up to 1 month
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