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Effects of probiotics on the clinical outcome and inflammatory response in gastric cancer surgery

Effects of probiotics on the clinical outcome and inflammatory response in gastric cancer surgery: A double blinded placebo controlled randomized control trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044463
Enrollment
88
Registered
2022-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: C169- Malignant neoplasm of stomach, unspecified

Interventions

Intervention1: Probiotics: Participants will receive two probiotic sachets (0.5gm each) with early enteral feeds twice a day until day 10 after surgery. Each sachet consists of Streptococcus faecalis

Sponsors

IMRF Intramural research fund JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients who are more than 18 years of age, undergoing subtotal gastrectomy for carcinoma stomach

Exclusion criteria

Exclusion criteria: 1. All patients who have received probiotics for a duration of 6 months before surgery. 2. Patients undergoing laparoscopic gastrectomy. 3. Recurrent carcinoma of stomach. 4. Presence of other malignancy. 5. Received neoadjuvant therapy. 6. Patients diagnosed with IBD. 7. Patients with coexistence of severe concomitant illness like organ failures 8. Immunocompromised patients. 9. Pregnancy or lactating women.

Design outcomes

Primary

MeasureTime frame
To determine if the administration of probiotic will reduce the length of hospital stay and inflammatory markers (TNF-alpha,TLC, IL-6, IL-8 ) in patients undergoing surgical resection for gastric cancer. Timepoint: pre operative, post operative day 10

Secondary

MeasureTime frame
To study the role of probiotics in patients undergoing surgery for gastric cancer on the following: 1. Postoperative clinical outcomes((time to return of bowel movement as measured by passage of flatus, time to first passage of stools, time to start of oral diet, duration of drains kept, duration of antibiotic therapy, length of hospital stay, mortality, post operative complications such as fever, surgical site infection, anastomotic leak, stump blow out, vomiting, diarrhea, pulmonary infection, intolerance to early enteral feed and Clavien-Dindo grading of post-operative complications) 2. Nutritional status (hemoglobin, albumin, BMI and transferrin) 3. Immune function (levels of IgG, IgA and IgM) 4. Risk Factors for the postoperative complication Timepoint: pre operative, post operative day 10

Countries

India

Contacts

Public ContactDr Debolina Pal

JIPMER

anandhiramesh76@yahoo.in9487781661

Outcome results

None listed

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