Using probiotics to reduce the side effects and toxicities caused by chemoradiation treatment in patients of esophageal, colon, rectal and anal canal cancer.

Characterization of gut dysbiosis in Gastrointestinal Malignancies and exploration of probiotics supplementation on therapeutic outcome in patients receiving chemoradiation in these malignancies. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064552

Enrollment

360

Registered

2024-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: C211- Malignant neoplasm of anal canal Health Condition 2: C189- Malignant neoplasm of colon, unspecified Health Condition 3: C159- Malignant neoplasm of esophagus, unspecified Health Condition 4: C20- Malignant neoplasm of rectum

Interventions

Intervention1: Probiotics: Probiotics supplementation will have a combination of Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus brevis CD2 and Saccharomyces boulardii. One capsule tw

Eligibility

Inclusion criteria

Inclusion criteria: 1. Biopsy proven cases of inoperable cases of carcinoma esophagus in which definitive chemoradiation is planned. 2. Biopsy proven cases of carcinoma colon. 3. Patient who have completed radical surgery in the form of hemi colectomy. 4. Patient in whom adjuvant chemotherapy is planned. 5. Biopsy proven cases of carcinoma rectum in which neoadjuvant chemoradiation is planned before definitive surgery. 6. Biopsy proven cases of carcinoma anal canal in which definitive chemoradiation is planned. 7. Karnofsky Performance Status KPS greater than 60 percent.

Exclusion criteria

Exclusion criteria: 1. Patients who refuse to give their consent. 2. Serious co morbid diseases. 3. Post op patients. 4. History of any prior cancer, or coexisting tumours. 5. Patients with Immunity diseases Autoimmunity or Immunodeficiency. 6. Prior GI toxicities 7. Prior history of radiotherapy administration. 8. Prior probiotics or oral antibiotics intake within 15 days. 9. Metastatic disease.

Design outcomes

Primary

Measure	Time frame
The probiotics administration will ameliorate CRT induced toxicities in GI cancer patients thereby improving the response rates and prolonged progression free survival.Timepoint: 04 years	—

Secondary

Measure	Time frame
The metagenomics approaches will help to gain insights into the functional potential of the gut microbiota and identify specific microbial pathways associated with probiotic supplementation in GI cancer patients.Timepoint: 04 years	—

Countries

India

Contacts

Public ContactMohammad Akram

Aligarh Muslim University

akramhayat@gmail.com8791385633

Outcome results

None listed

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