Benefit of prebiotic in reducing loose motions among cancer patients experiencing radiotherapy

Efficacy of partially hydrolysed guar gum (PHGG) in reducing risk of diarrhea among cancer patient undergoing pelvic radiation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17271186

Enrollment

Registered

2019-11-09

Start date

2015-05-30

Completion date

Unknown

Last updated

2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer patient (endometrium, cervix, colon, rectum and prostate) undergoing pelvic radiation treatment Cancer

Interventions

Eligible patients were allocated randomly (Random Allocation Software Ver 1.0 May 2004) to receive either 10 g twice daily PHGG or 10 g twice daily maltodextrin (placebo). Duration of supplementation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cancer patient with pelvic cancers scheduled for external beam radiotherapy (EBRT) treatment as an outpatient or inpatient with EBRT dose 40 Gray and above, 180-220 cGy per fraction

Exclusion criteria

Exclusion criteria: Patients receiving enteral or parenteral nutrition or terminally ill

Design outcomes

Primary

Measure	Time frame
Measured at baseline, day 7 (for microbiome growth only), day 14, day 28 and day 45: 1. Diarrhea incidence and frequency classified according to the National Cancer Institute Common Terminology Criteria (NCI-CTC); a reference of cancer patient’s managements Ministry of Health Malaysia 2017 (MOH Systemic Therapy Protocol 2016) 2. Stool formations recorded daily by patients based on Bristol Stool Charts	—

Measure

Time frame

Measured at baseline, day 7 (for microbiome growth only), day 14, day 28 and day 45: 1. Diarrhea incidence and frequency classified according to the National Cancer Institute Common Terminology Criteria (NCI-CTC); a reference of cancer patient’s managements Ministry of Health Malaysia 2017 (MOH Systemic Therapy Protocol 2016) 2. Stool formations recorded daily by patients based on Bristol Stool Charts

—

Secondary

Measure	Time frame
Measured at baseline, day 7 (for microbiome growth only), day 14, day 28 and day 45: 1. Patient's self-collected fecal samples preserved in Stool Nucleic Acid Collection and Transport Tubes (Norgen, Canada) at 4°C until further processing. Fecal DNA extracted using Stool DNA Extraction kit (Qiagen, Germany). DNA samples assessed for their quality and quantity using NanoDrop Spectrophotometer (Thermo Scientific, UK). DNA samples stored at -20°C until further use. 2. Quantification of Bifidobacterium spp. and all bacteria cells based on copy number of 16s rDNA region performed using probe-based qPCR assay by 1st Base Laboratories Sdn Bhd (604944-X). All reactions performed in a 25 µL reaction system of (Thermo Scientific™ Maxima Probe qPCR Master Mix (2X) 3. Comprehensive nutritional status assessed using Scored Patient-Generated Subjective Global Assessment (PG-SGA) 4. Quality of Life (QoL) assessed using EORTC QLQ-C30 version 3.0 questionnaire	—

Measure

Time frame

Measured at baseline, day 7 (for microbiome growth only), day 14, day 28 and day 45: 1. Patient's self-collected fecal samples preserved in Stool Nucleic Acid Collection and Transport Tubes (Norgen, Canada) at 4°C until further processing. Fecal DNA extracted using Stool DNA Extraction kit (Qiagen, Germany). DNA samples assessed for their quality and quantity using NanoDrop Spectrophotometer (Thermo Scientific, UK). DNA samples stored at -20°C until further use. 2. Quantification of Bifidobacterium spp. and all bacteria cells based on copy number of 16s rDNA region performed using probe-based qPCR assay by 1st Base Laboratories Sdn Bhd (604944-X). All reactions performed in a 25 µL reaction system of (Thermo Scientific™ Maxima Probe qPCR Master Mix (2X) 3. Comprehensive nutritional status assessed using Scored Patient-Generated Subjective Global Assessment (PG-SGA) 4. Quality of Life (QoL) assessed using EORTC QLQ-C30 version 3.0 questionnaire

—

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026