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

NCT ID: NCT04678349

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-11-29

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PHGG

Patient who met inclusion criteria and consented during intervention period will be assigned as PHGG group. Surgical medical officer will obtain consent from eligible subject. After consented, subjects will be assessed weight and PG-SGA during admission. They 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. Staff nurse in charged will monitor compliance of subject on the PHGG. Daily stoma output \& consistency will be recorded and daily energy protein intake will be assessed by dietitian in charged. Renal profile will be taken daily as routine procedure for patients with ileostomy.

Group Type EXPERIMENTAL

PHGG

Intervention Type DIETARY_SUPPLEMENT

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.

CG

Historical records of patients with ileostomy under conventional care from January 2016 to June 2019 (before started on PHGG) will be assessed and traced retrospectively from the medical system. Data will be recorded in data collection sheet.

Group Type OTHER

conventional care

Intervention Type OTHER

follow low fibre diet and anti-diarrhea drugs

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

conventional care

follow low fibre diet and anti-diarrhea drugs

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Malaysia

OTHER_GOV

Sponsor Role collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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HO CHIOU YI

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ChiouYi Ho

Role: PRINCIPAL_INVESTIGATOR

Department of Dietetics and Food Service, Institut Kanser Negara

Locations

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National Cancer Institute

Putrajaya, , Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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NMRR-19-3119-51323

Identifier Type: -

Identifier Source: org_study_id

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