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Low Fiber Diet vs. Regular Diet for Ileostomy Patients

N/A

Recruiting

Led By Karen Zaghiyan, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days postoperatively

Awards & highlights

Study Summary

This trial is studying if a low fiber diet reduces post-operative ileus or obstruction in patients with ileostomies.

Who is the study for?

This trial is for adults aged 18-90 undergoing certain colorectal surgeries that result in an ileostomy. Participants must not have allergies to anesthesia, be able to consent, and should not require ICU care post-surgery. Pregnant individuals, those with short-bowel syndrome or jejunostomies, or patients who cannot eat after surgery are excluded.Check my eligibility

What is being tested?

The study compares the effects of a low fiber diet versus a regular diet on patients with new ileostomies from day one after surgery. It looks at how these diets affect the risk of intestinal blockage, readmission rates within 30 and 90 days, hospital stay length, stoma output control needs, nausea levels, pain intensity and overall life quality.See study design

What are the potential side effects?

Potential side effects may include increased risk of high stoma output requiring anti-diarrheal medication when on a regular diet compared to a low fiber diet. Patients might also experience varying levels of nausea and pain depending on their assigned diet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of postoperative ileus and obstruction

Secondary outcome measures

Average maximum daily nausea score

Average maximum daily pain score

Hospital length of stay

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Regular dietExperimental Treatment1 Intervention

Patients in this arm will receive regular diet starting postoperative day 1. This will be the experimental arm.

Group II: Low fiber dietActive Control1 Intervention

Patients in this arm will receive low fiber diet starting postoperative day 1. This is currently the standard protocol at our institution.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Regular diet

2021

Completed Phase 3

~190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

499 Previous Clinical Trials

164,697 Total Patients Enrolled

1 Trials studying Intestinal Obstruction

6 Patients Enrolled for Intestinal Obstruction

Karen Zaghiyan, MDPrincipal Investigator - Cedars-Sinai Medical Center

Cedars-Sinai Medical Center, Karen Zaghiyan, Md

5 Previous Clinical Trials

405 Total Patients Enrolled

Media Library

Low fiber diet Clinical Trial Eligibility Overview. Trial Name: NCT04675606 — N/A

Intestinal Obstruction Research Study Groups: Low fiber diet, Regular diet

Intestinal Obstruction Clinical Trial 2023: Low fiber diet Highlights & Side Effects. Trial Name: NCT04675606 — N/A

Low fiber diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04675606 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this research study?

"Affirmative. Clinicaltrials.gov mentions that this medical experiment, which commenced on October 21st 2020, is still welcoming participants. 160 patients are needed from a single site for the study's completion."

Answered by AI

Is the research team currently welcoming participants?

"As seen on clinicaltrials.gov, this scientific trial has commenced recruitments of potential candidates and was posted on October 21st 2020 with its latest update being made in 2022."

Answered by AI

Does the research team accept participants who are aged 65 or older?

"This trial's eligibility criteria are limited to individuals between the ages of 18 and 90. There also exist two clinical trials for minors and twenty for seniors."

Answered by AI

What are the eligibility criteria for this trial?

"This clinical trial is recruiting 160 volunteers aged between 18 and 90 who suffer from intestinal obstruction. Specifcally, it seeks male or female participants in ASA physical Class I-III undergoing elective or urgent major laparoscopic/open colorectal procedures resulting in loop/end ileostomy creation; with the latter not requiring ICU admission postoperatively."

Answered by AI

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