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Amino Acid
Alanine for Fructose Intolerance
N/A
Recruiting
Led By Satish Rao, Md, PhD
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18-70 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up less than 6 months
Awards & highlights
Study Summary
This trial is investigating whether co-administration of an amino acid (alanine) with fructose can help people who have trouble absorbing fructose.
Who is the study for?
This trial is for adults aged 18-70 with diagnosed fructose malabsorption, confirmed by a breath test. It's not suitable for those with food allergies, recent antibiotics use, certain GI surgeries, bacterial overgrowth or lactose intolerance, cognitive issues preventing consent, opioid or specific medication use, diabetes or major illnesses like chronic pancreatitis.Check my eligibility
What is being tested?
The study tests if taking alanine can help people absorb fructose better and reduce gastrointestinal symptoms compared to a placebo. Participants will drink an alanine solution followed by a fructose solution and undergo regular testing over four hours to measure the effects.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include typical gastrointestinal reactions due to fructose ingestion such as bloating, gas, abdominal pain or discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ less than 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~less than 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decrease breath Hydrogen and/or Methane production
Secondary outcome measures
Occurrence or severity of GI symptoms during the test
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Alanine - 25Experimental Treatment1 Intervention
Subjects will receive 25 grams of alanine.
Group II: Alanine - 12.5Experimental Treatment1 Intervention
Subjects will receive 12.5 grams of alanine
Group III: PlaceboPlacebo Group1 Intervention
Subjects will receive placebo (mix of sugar and salt).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alanine
2013
N/A
~130
Find a Location
Who is running the clinical trial?
University of IowaOTHER
446 Previous Clinical Trials
879,402 Total Patients Enrolled
Teikyo UniversityOTHER
8 Previous Clinical Trials
12,079 Total Patients Enrolled
Augusta UniversityLead Sponsor
211 Previous Clinical Trials
84,968 Total Patients Enrolled
3 Trials studying Fructose Intolerance
1,160 Patients Enrolled for Fructose Intolerance
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have bacterial overgrowth or lactose intolerance.You have been diagnosed with fructose malabsorption through a specific breath test after consuming fructose.I have not taken antibiotics in the last 3 months.I have a major illness such as diabetes or inflammatory bowel disease.I have not had GI surgery, except for removal of my appendix, gallbladder, a C-section, or uterus.You have known allergies to certain foods.I am able to understand and give consent for my treatment.I am between 18 and 70 years old.I am currently using opioids, Tegaserod, laxatives, or enemas.I have diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Alanine - 25
- Group 3: Alanine - 12.5
Awards:
This trial has 0 awards, including: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.
Do I meet the criteria to partake in this research initiative?
"This medical trial is seeking individuals aged 18-70 who suffer from fructose intolerance, with a target recruitment of approximately 100 participants."
Answered by AI
Are there any remaining slots available for enrolment in this clinical trial?
"As indicated by clinicaltrials.gov, this medical trial is presently enlisting volunteers. The posting was originally made on September 1st 2007 with the most modern changes being applied on July 19th 2022."
Answered by AI
How many people are enrolled in this research project?
"Affirmative. According to information available on clinicaltrials.gov, the trial first posted on September 1st 2007 is now actively seeking participants. A total of 100 volunteers are required at a single medical site with the latest update taking place on July 19th 2022."
Answered by AI
Does this research accommodate individuals over the age of sixty?
"As per the trial's inclusion criteria, only participants aged 18 to 70 can join."
Answered by AI
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