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EFFECT OF PROBIOTICS FOR THE PREVENTION OF ACUTE RADIATION-INDUCED DIARRHOEA AMONG CERVICAL CANCER PATIENTS

Effect of probiotics for the prevention of acute radiation-induced diarrhoea among cervical cancer patients: a randomized double-blind placebo-controlled study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20170314001
Enrollment
Unknown
Registered
2017-03-14
Start date
2016-05-02
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Radiation&#45

Interventions

Biogurt ® &#45
each capsule contains: Functional yogurt 300 mg containing 1.75 billion lyophilized live Lactobacillus acidophilus LA&#45
5 plus Bifidobacterium animalis subsp. lactis BB&#45
12 (produced by Fame Pharmaceuticals&#44
Myanmar&#44
Reg No. &#45
TMR 011383 (0615)&#44
MFD &#45
April&#44
2016&#44
EXP &#45
2018) The probiotic group was given one capsule three times daily (each capsule contains: Functional yogurt 300 mg containing 1.75 billion lyophilized live Lactobacillus acidophilus LA&#45
12)&#44
beginning from the first day of radiotherapy&#44
continuing every day until the end of radiotherapy. ,The placebo group received the placebo capsules (containing starch of equal weight as the study drug) which had identical colour and size as the st
Active Comparator Other,Placebo Comparator No treatment
probiotic group,placebo group

Sponsors

Self funded
Lead Sponsor
Self funded
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with the cervical cancer (FIGO staging – I B and above) who will receive external beam radiotherapy for a minimum of 40 Gy at pelvis level with or without concurrent chemotherapy 2. Age – above 18 years 3. Patients with the ECOG performance status (0-2)

Exclusion criteria

Exclusion criteria: 1. Patients with the previous history of pelvic radiotherapy 2. Patients with the history of intestinal resection 3. Patients with the medical history of irritable bowel syndrome, malabsorption syndrome, inflammatory bowel disease and ileostomy 4. Patients with the history of daily use of antidiarrhoeal medication before radiotherapy 5. Patients with diarrhoea at the beginning of study 6. Patients with immunosuppression (HIV positive, immunosuppressive drugs) 7. Patients with structural heart diseases and those with prosthetic heart valves

Design outcomes

Primary

MeasureTime frame
incidence of radiation-induced diarrhoea assessed everyday with face-to-face interview percentage,Severity of the radiation-induced diarrhoea – by Common Terminology Criteria for Adverse Events (C daily Grades – face-to-face interview—

Secondary

MeasureTime frame
Onset of radiation-induced diarrhoea daily Days/Gray face-to-face interview,The use of the antidiarrhoeal medication – loperamide daily percentage, face-to-face interview, ,Dose of Loperamide daily mg, face-to-face interview, ,The time to the use of loperamide from the start of radiation daily days, face-to-face interview, ,Severity of abdominal pain – (CTCAE Version 4.0) daily grades, face-to-face interview,Episode of abdominal pain in days daily days, face-to-face interview, ,Interruption of radiotherapy due to diarrhoea daily percentage, face-to-face interview,—

Countries

Myanmar

Contacts

Public ContactYe Htut Linn

Department of Pharmacology, University of Medicine 1, Yangon

dryehtutlinn@gmail.com+959977235192

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026