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临床试验/NCT07574892
NCT07574892尚未招募1 期

Reestablishing Normal Gut-Brain Interaction in Anorexia Nervosa With Normal Gut Microbiota: Restart

Haukeland University Hospital4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年12月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
36
试验地点
4
主要终点
Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation

研究概览

简要总结

In this pilot study 36 patients with anorexia nervosa (AN) will be randomized to either treatment with psychotherapy as usual (TAU) or TAU plus fecal microbiota transplantation (FMT). The transplantation will be performed when refeeding has started. Patients randomized to TAU+FMT will choose either capsules or gastroscopy as source of FMT. One week after FMT gut microbiota will be collected and analyzed and compared with microbiota composition at baseline. The two groups are then followed during psychotherapy to assess whether it is feasible to give FMT during psychotherapy to study the effects on outcome. In addition, this pilot study is aiming at paving the way for performing larger studies to assess whether FMT improves outcome from psychotherapy when given in combination with psychotherapy in patients with AN.

详细描述

Around fifty percent of the patients who enter psychotherapy for anorexia nervosa (AN) drop out from the psychotherapy. Nearly all patients who are unable to complete treatment have significant deterioration shortly after premature ending of psychotherapy. During the development of AN, the microbes in the gut are significantly altered probably due to malnutrition. Some studies indicate that these alterations in the composition of gut microbiota play a role in the maintenance of AN. In this study we are aiming at assessing the feasibility of combining psychotherapy with improvement of nutritional status with fecal microbiota transplantation (FMT). By improving the nutritional status of the patient before transplantation the transplant may have better survival with improved outcome. In this pilot study 36 patients who have at least one failed treatment attempt will be included. The transplantation will be performed when refeeding has started. Patients randomized to TAU+FMT will choose either capsules or gastroscopy as source of FMT. One week after FMT gut microbiota will be collected and analyzed and compared with microbiota composition at baseline. The two groups are then followed during psychotherapy to assess whether it is feasible to give FMT during psychotherapy to study the effects on outcome. In addition, this pilot study is aiming at paving the way for performing larger studies to assess whether FMT improves outcome from psychotherapy when given in combination with psychotherapy in patients with AN.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age 18 years or more Starting outpatient psychotherapy for anorexia nervosa At least one failed qualified treatment attempt

排除标准

  • •Age below 18 years BMI below 16 kg/m2 Significant electrolyte disturbances Other signs of medical instability Presence of systemic disease, Immune deficiency Treated with immune-modulating medication Pregnancy Planning pregnancy Lactations Having undergone abdominal surgery (with the exception of appendectomy, cholecystectomy, caesarian section and hysterectomy) severe psychiatric disease (except anorexia nervosa) Use of probiotics or treatment with antibiotics within 8 weeks prior to study entry.

研究组 & 干预措施

Patients receiving TAU in combination with FMT

Experimental

The 18 patient with anorexia nervosa randomized to this arm will receive treatment with psychotherapy for anorexia nervosa as usual (TAU) in combination with a single dose fecal microbiota transplantation (FMT)

干预措施: Psychotherapy as usual combined with single dose normal gut microbiota (Biological)

Psychotherapy treatment as usual (TAU)

Active Comparator

The 18 patient with anorexia nervosa randomized to this arm will receive treatment with psychotherapy for anorexia nervosa as usual (TAU)

干预措施: Psychotherapy treatment as usual (TAU) (Other)

结局指标

主要结局

Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation

时间窗: 1 year

A single dose of fecal microbiota transplantation will be administered when the patients has established a nutritional status allowing survival of the transplant. Then the patients will be followed to the end of psychotherapy. Assessments will include description of gut microbiota composition and questionnaires describing the clinical course of the eating disorder.

次要结局

  • Body mass index (BMI)(1 year)
  • Eating disorder evaluation quesionnaire (EDE-Q) score(1 year)
  • Clinical impairment assessment questionnaire (CIA)(1 year)
  • ROME 4(1 year)
  • Irritable bowel syndrome symptome severity score (IBS-SSS)(1 year)
  • Gastrointestinal symptom rating scale for IBS (GSRS-IBS)(1 year)
  • Fecal microbiota composition(1 week)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (4)

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