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Tests treatment safety and results for Constipation - Functional
Official title The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study
ClinicalTrials.gov ID: NCT07387952
What this study is testing
- What it's testing
- Chronic constipation is a common gastrointestinal disease with a global prevalence of about 15%, significantly affecting daily life and quality of life. Traditional treatments primarily rely on laxatives, which may lead to adverse effects with prolonged use, while surgical interventions have limited patient acceptance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age: 18 to 70.
- Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions:
- Symptom requirements: The following at least 2 items should occur in ≥25% of bowel movements: a. Straining during defecation; b. Hard stool (Bristol...
- It is rare to have loose stools without laxatives.
- Exclusion of irritable bowel syndrome (IBS): IBS diagnosis criteria not meeting Rome IV.
You likely can't join if
- Pregnancy or lactation.
- Unable to take the intervention product or complete the examination as required.
- Language expression disorder or mental illness.
- Physical examination showed severe liver and kidney dysfunction.
- Acute gastrointestinal disease within 4 weeks.
- Constipation caused by surgery in the past 4 weeks.
See the full eligibility criteria
- Age: 18 to 70.
- Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions:
- Symptom requirements: The following at least 2 items should occur in ≥25% of bowel movements: a. Straining during defecation; b. Hard stool (Bristol Stool Classification score 1-2); c. Feeling of incomplete evacuation...
- It is rare to have loose stools without laxatives.
- Exclusion of irritable bowel syndrome (IBS): IBS diagnosis criteria not meeting Rome IV.
- Disease course requirements: Symptoms persist for at least 6 months and meet the above criteria within the last 3 months.
- Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective.
- Pregnancy or lactation.
- Unable to take the intervention product or complete the examination as required.
- Language expression disorder or mental illness.
- Physical examination showed severe liver and kidney dysfunction.
- Acute gastrointestinal disease within 4 weeks.
- Constipation caused by surgery in the past 4 weeks.
- History or abnormal examination: cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness, stroke, heart disease, cirrhosis, renal failure, hematopoietic system...
- Participation in other clinical trials within 3 months prior to enrollment.
- Other health problems are not suitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.