Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT06744751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2024-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on the Effects of Combined FMT on Gut Microbiota and Eating Disorder Symptoms in AN
Sponsor:
Shanghai Mental Health Center
Organization:
Study Overview
Official Title:
A Randomsized Controlled Study on the Effects of Combined Fecal Microbiota Transplantation on Gut Microbiota and Eating Disorder Symptoms in Patients With Anorexia Nervosa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine if Fecal Microbiota Transplantation (FMT) is effective in treating Anorexia Nervosa (AN). The study will also explore how FMT works. The main questions it aims to answer are:
1. What is the efficacy of combined FMT treatment in patients with AN?
2. What is the relationship between treatment efficacy and changes in gut microbiota, and what mechanisms underlie the effects of FMT in treating AN? Researchers will compare FMT to a placebo (a look-alike substance that contains no active ingredients) to see if FMT is effective in treating AN.
Participants will:
* Be hospitalized
* Take FMT or placebo daily for 6 days
* Provide stool and blood samples before and after FMT
* Visit the clinic every 4 weeks for check-ups and tests
1. What is the efficacy of combined FMT treatment in patients with AN?
2. What is the relationship between treatment efficacy and changes in gut microbiota, and what mechanisms underlie the effects of FMT in treating AN? Researchers will compare FMT to a placebo (a look-alike substance that contains no active ingredients) to see if FMT is effective in treating AN.
Participants will:
* Be hospitalized
* Take FMT or placebo daily for 6 days
* Provide stool and blood samples before and after FMT
* Visit the clinic every 4 weeks for check-ups and tests
Detailed Description:
Anorexia Nervosa (AN) is a chronic, challenging psychiatric disorder characterized by an intense fear of gaining weight, extreme weight loss, severe malnutrition, and physical wasting. The core behavioral trait of AN is a "persistent restriction of energy intake," which results in low body weight, malnutrition, and, in severe cases, death due to multiple organ failure. Consequently, AN is considered the most fatal mental disorder. With globalization and rapid economic development in China, dieting and weight loss have become fashionable. A domestic survey found that 49.9% to 55.7% of female college students engage in dieting and weight loss behaviors, and the prevalence of AN in China has been increasing rapidly. Thus, AN is becoming a significant public health issue in China.
More than 90% of AN patients experience functional gastrointestinal symptoms (FGS), including bloating, constipation, and difficulty swallowing. These FGS are largely associated with disordered eating behaviors. For example, patients with restrictive eating often prefer high-fiber, low-fat, and low-carbohydrate foods, which can lead to symptoms such as early satiety, constipation, and flatulence. Therefore, disordered eating behavior can contribute to abnormal gastrointestinal function, while, conversely, disordered GI function can exacerbate the severity of AN, hinder patients from resuming normal eating habits, and impact the effectiveness of clinical treatment. Recent studies increasingly suggest that gut microbes play an essential role in influencing GI symptoms in psychiatric disorders.
The human gastrointestinal tract hosts billions of microorganisms, with a total gene count about 150 times greater than that of the human genome. These microorganisms are closely linked to the regulation of gastrointestinal function and have also been shown to influence mood, eating behavior, appetite, and nutrient metabolism. Researchers have discovered that Nod2 receptors expressed by inhibitory neurons in the hypothalamus and arcuate nucleus can directly sense cytosolic peptides produced by bacteria, regulating feeding behavior and suggesting that gut microbes may influence appetite through the brain-gut axis. Cross-sectional studies have found abnormalities in gut flora composition or metabolites in AN patients, while longitudinal studies have shown that the abundance of gut flora increases after weight regain in AN patients; however, flora diversity and gastrointestinal symptoms do not fully return to normal. This suggests that, while body weight may normalize, the gut microbiome remains "unhealthy."
Fecal Microbiota Transplantation (FMT) involves transplanting healthy intestinal flora into a patient's gut. FMT primarily treats digestive diseases like intestinal infections, irritable bowel syndrome, Crohn's disease, and chronic diarrhea, effectively relieving symptoms such as constipation and diarrhea. FMT has also been used to treat neuropsychiatric disorders like autism, mood disorders, ADHD, and sleep disorders. Studies have shown that FMT can alleviate symptoms of depression, anxiety, and sleep disturbances caused by chronic stress, reduce inflammatory responses to slow the progression of Alzheimer's disease, and improve symptoms in patients with autism spectrum disorder (ASD). Although some case reports describe FMT's application in AN patients, there is still a lack of extensive randomized controlled trials to validate its efficacy.
Currently, no studies have explored the role of FMT combined with conventional treatments in improving AN's clinical symptoms. Given that mood and GI symptoms are common comorbidities of AN, and there is no effective pharmacologic treatment for these symptoms, FMT offers a promising new strategy to enhance clinical outcomes as a supportive treatment for AN.
More than 90% of AN patients experience functional gastrointestinal symptoms (FGS), including bloating, constipation, and difficulty swallowing. These FGS are largely associated with disordered eating behaviors. For example, patients with restrictive eating often prefer high-fiber, low-fat, and low-carbohydrate foods, which can lead to symptoms such as early satiety, constipation, and flatulence. Therefore, disordered eating behavior can contribute to abnormal gastrointestinal function, while, conversely, disordered GI function can exacerbate the severity of AN, hinder patients from resuming normal eating habits, and impact the effectiveness of clinical treatment. Recent studies increasingly suggest that gut microbes play an essential role in influencing GI symptoms in psychiatric disorders.
The human gastrointestinal tract hosts billions of microorganisms, with a total gene count about 150 times greater than that of the human genome. These microorganisms are closely linked to the regulation of gastrointestinal function and have also been shown to influence mood, eating behavior, appetite, and nutrient metabolism. Researchers have discovered that Nod2 receptors expressed by inhibitory neurons in the hypothalamus and arcuate nucleus can directly sense cytosolic peptides produced by bacteria, regulating feeding behavior and suggesting that gut microbes may influence appetite through the brain-gut axis. Cross-sectional studies have found abnormalities in gut flora composition or metabolites in AN patients, while longitudinal studies have shown that the abundance of gut flora increases after weight regain in AN patients; however, flora diversity and gastrointestinal symptoms do not fully return to normal. This suggests that, while body weight may normalize, the gut microbiome remains "unhealthy."
Fecal Microbiota Transplantation (FMT) involves transplanting healthy intestinal flora into a patient's gut. FMT primarily treats digestive diseases like intestinal infections, irritable bowel syndrome, Crohn's disease, and chronic diarrhea, effectively relieving symptoms such as constipation and diarrhea. FMT has also been used to treat neuropsychiatric disorders like autism, mood disorders, ADHD, and sleep disorders. Studies have shown that FMT can alleviate symptoms of depression, anxiety, and sleep disturbances caused by chronic stress, reduce inflammatory responses to slow the progression of Alzheimer's disease, and improve symptoms in patients with autism spectrum disorder (ASD). Although some case reports describe FMT's application in AN patients, there is still a lack of extensive randomized controlled trials to validate its efficacy.
Currently, no studies have explored the role of FMT combined with conventional treatments in improving AN's clinical symptoms. Given that mood and GI symptoms are common comorbidities of AN, and there is no effective pharmacologic treatment for these symptoms, FMT offers a promising new strategy to enhance clinical outcomes as a supportive treatment for AN.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: