Rectal CancerNCT04678349
The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy
A study testing PHGG and conventional care in people with Rectal Cancer, run by Universiti Putra Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- PHGG and conventional care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 May 2021to 29 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients with ileostomy
- At least 18 years of age
- Malaysian
Who cannot join
- Not cancer patients with ileostomy
- Patients who participate in other study at the same time
- Vulnerable subjects
- Palliative patients
- Patient has fistula
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Rectal Cancer
- Being tested
- PHGG, conventional care
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHGGDietary 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.
conventional careOther
follow low fibre diet and anti-diarrhea drugs
| Study group | Role | What they receive |
|---|---|---|
| PHGG | Experimental | 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. Receives: Dietary Supplement: PHGG |
| CG | Other | 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. Receives: Other: conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ileostomy stoma output
consistency (bristrol stool chart; range 1-7; 1 hard while 7 watery)
Measured: up to 1 month
ileostomy stoma output
volume (ml)
Measured: up to 1 month
Secondary outcomes (4)
Length of hospital stay
days of hospital stays
Measured: up to 1 month
Readmission within 30-days discharged
readmit to ward due to complications after discharge
Measured: up to 1 month
Dietary intake
energy (kcal/day)
Measured: up to 1 month
dietary intake
protein intake (g/day)
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 May 2021
- Primary completion28 Sep 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, Malaysia
- Responsible party
- Principal investigator, HO CHIOU YI, National Cancer Institute, Malaysia
- Investigators
- ChiouYi Ho, Principal investigator, Department of Dietetics and Food Service, Institut Kanser Negara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678349
- Sponsor's protocol ID
- NMRR-19-3119-51323
- Status last verified
- Nov 2022
- First submitted
- 24 Nov 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy
- ClinicalTrials.gov ID
- NCT04678349
- Acronym / sponsor ID
- NMRR-19-3119-51323
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- National Cancer Institute, Malaysia
- Study start
- 1 May 2021 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 21 Dec 2020 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHGG | Experimental | Dietary Supplement: PHGGPatient 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. |
| CG | Other | Other: conventional careHistorical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cancer patients with ileostomy
- At least 18 years of age
- Malaysian
Key exclusion criteria (5 listed)
- Not cancer patients with ileostomy
- Patients who participate in other study at the same time
- Vulnerable subjects
- Palliative patients
- Patient has fistula
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 |
|---|---|---|
| PHGGSubjects 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. | Dietary supplement | PHGG |
| conventional carefollow low fibre diet and anti-diarrhea drugs | Other | CG |
Primary outcome
ileostomy stoma output
Time frame: up to 1 month
consistency (bristrol stool chart; range 1-7; 1 hard while 7 watery)
ileostomy stoma output
Time frame: up to 1 month
volume (ml)
4 secondary outcomes
Length of hospital stay
Time frame: up to 1 month
Readmission within 30-days discharged
Time frame: up to 1 month
Dietary intake
Time frame: up to 1 month
dietary intake
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
ChiouYi Ho principal investigator
Department of Dietetics and Food Service, Institut Kanser Negara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHGG and conventional care in people with Rectal Cancer, run by Universiti Putra Malaysia at 1 site in Malaysia.
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 5 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: finished, as of the sponsor's last update on 4 Nov 2022. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ileostomy stoma output (time frame: up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2022.