A Single-Centered Clinical Study to Evaluate the Safety and Efficacy of Polyethylene Glycol 3350 and Electrolytes for Oral Solution in Patients undergoing Colonoscopy or Intestinal Surgery

Phase 3

• Conditions: Health Condition 1: O- Medical and SurgicalHealth Condition 2: O- Medical and Surgical

• Registration Number: CTRI/2024/06/069347
• Lead Sponsor: TIL Healthcare Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects in the age group of 18 to 65 years.

2. Subjects with no bowel surgical procedure.

3. Subjects who have to undergo colonoscopy or intestinal surgery.

4. Willingness to provide written informed consent to participate in the study.

Exclusion Criteria

1.Pregnant women and lactating mother.

2.Subjects with colonic resections and/or ileostomies.

3.Inflammatory bowel disease.

4.Colonic optimization by prior colonoscopy with poor preparation.

5.Oral iron intake in the past 10 days.

6.Subjects who need Emergency colonoscopy, have Diabetes or Chronic kidney disease requiring dialysis.

7.Subjects with coexisting features of acute systemic disease like septicemia, meningitis, pneumonia, etc.

8.Subjects with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohn’s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose).

9.Participation in any clinical trial in the last 3 months prior to screening.

10.Hypersensitivity to any of the components composed in preparations.

11.Severe psychiatric illness (schizophrenia).

12.Low IQ to understand bowel preparation.

13.Severe constipation of less than 1 weekly stool.

14.Chronic diarrhea with high rate of 4 or greater than 4 daily evenly loose consistency stools for more than 4 weeks.

15.Unbalanced heart diseases (ischemic cardiopathology, congestive heart failure, unstable angina, arrhythmias and untreatable high blood pressure).

16.Presence of any other medical or surgical condition which as per the judgment of the principal investigator is not conducive for trial participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified