Oral Fecal Microbiota Transplantation Capsules from Healthy Donors in Patients with Locally Advanced, Resectable Gastric or Gastro-esophageal Junction Adenocarcinoma

Phase 2

• Conditions: gastro-esophageal cancer; stomach and esophageal cancer; 10017991

• Registration Number: NL-OMON56807
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

Patients
-Resectable adenocarcinoma of the stomach or gastro*esophageal junction;
planned start with neo-adjuvant FLOT
-Patient is fit for surgery

Healthy fecal donors
-Lean body mass of 80-90%

Exclusion Criteria

Patients
Past (within 5 years) or current history of malignancy other than entry
diagnosis interfering with prognosis of gastro-esophageal cancer, not including
superficial and adequately treated skin and cervical malignancies.
History of a non-malignant disease of the digestive tract, such as celiac
disease, chronic diarrhoea (>=3 stools/day for >4 weeks), chronic obstipation
(<2 defecations/week for >3 months), Irritable Bowel Syndrome (IBS) (according
to Rome IV criteria) or Inflammatory Bowel Disease (IBD).
Uncontrolled (bacterial) infections

Healthy fecal donors
-Use of antibiotics
-Infections such as HIV, hepatitis B or C
-Smoking or drug use
-Parasite infection
-Gastro-intestinal diseases such as IBS or IBD

Study & Design

• Study Type: Interventional
• Study Design: Not specified