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Fiber Supplementation for Post-Bariatric Surgery Patients (FSPB Trial)
N/A
Waitlist Available
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults ≥ 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
FSPB Trial Summary
This trial tests if a 30-day dose of potato starch helps bariatric patients, and if it increases short chain fatty acids in the body.
Who is the study for?
This trial is for adults over 18 who've had bariatric surgery at Dartmouth Medical Center, consume at least 60 grams of protein and 48 fl oz. of fluids daily. It's not for those allergic to potato starch, non-English speakers/writers, individuals over 550 lbs, or with surgical complications.Check my eligibility
What is being tested?
The study tests if taking potato starch for a month after bariatric surgery helps with gut health by increasing butyrate—a beneficial short chain fatty acid. Participants' tolerance and the body's response to the supplement are being monitored.See study design
What are the potential side effects?
Possible side effects may include gastrointestinal discomfort such as bloating, gas, constipation or diarrhea due to fiber intake from potato starch.
FSPB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
FSPB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gastrointestinal tolerance
Secondary outcome measures
Short-chain fatty acid
Other outcome measures
Hunger and food cravings
FSPB Trial Design
1Treatment groups
Experimental Treatment
Group I: Potato Starch SupplementExperimental Treatment1 Intervention
Participants will consume a 24 grams of potato starch on Days 1-15 and 48 grams of potato starch on Days 16-30.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Potato starch
2023
Completed Early Phase 1
~50
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,311 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I weighed more than 550 lbs at the time of my bariatric surgery.I am 18 years old or older.I have had complications from weight-loss surgery.I had weight loss surgery at Dartmouth Medical Center.You need to consume at least 60 grams of protein every day.You are allergic to potato starch.I cannot speak or write in English.
Research Study Groups:
This trial has the following groups:- Group 1: Potato Starch Supplement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process for this research activity still open?
"The clinical trial is presently seeking participants, as noted on the medical website. This study was published and last modified on February 13th 2023."
Answered by AI
What is the participant size for this clinical trial?
"Affirmative. As indicated on clinicaltrials.gov, this medical experiment is currently in the process of recruiting subjects. This trial was initially posted on February 13th 2023 and later revised on the same date; 30 participants must be signed up at a single location."
Answered by AI
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