Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota (Restart)
Reestablishing Normal Gut-Brain Interaction in Anorexia Nervosa With Normal Gut Microbiota: Restart
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：Stein Frostad, MD PhD
- 电话号码：+47 95003257
- 邮箱：stein.frostad@helse-bergen.no
研究联系人备份
- 姓名：Olivia B Helland, Master of Science
- 邮箱：olivia.bysheim.helland@helse-bergen.no
学习地点
-
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Haugesund
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Haugesund、Haugesund、挪威、5535
- Haugalandet distriktspsykiatriske senter
-
接触：
- Kenneth Eikeset, MD
- 邮箱：kenneth.eikeset@helse-fonna.no
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Møre og Romsdal
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Ålesund、Møre og Romsdal、挪威、6026
- Helse Møre og Romsdal
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接触：
- Dag AL Hoff, MD PhD
- 邮箱：Dag.Arne.Lihaug.Hoff@helse-mr.no
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Norway
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Bergen、Norway、挪威、5096
- Haukeland University Hospital in Helse Bergen
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Sola
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Stavanger、Sola、挪威、4050
- Sola distriktspsykiatriske senter
-
接触：
- Øystein Enger, Specialist Clinical Psychology
- 邮箱：oystein.enger@sus.no
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Age 18 years or more Starting outpatient psychotherapy for anorexia nervosa At least one failed qualified treatment attempt
Exclusion Criteria:
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Psychotherapy treatment as usual (TAU)
The 18 patient with anorexia nervosa randomized to this arm will receive treatment with psychotherapy for anorexia nervosa as usual (TAU) |
Psychotherapy treatment as usual (TAU) |
|
实验性的：Patients receiving TAU in combination with FMT
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) |
Psychotherapy treatment as usual (TAU) combined with single dose normal fecal microbiota (FMT) will be compared with TAU |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation
大体时间：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. |
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body mass index (BMI)
大体时间：1 year
|
Body mass index to assess weight development |
1 year
|
|
Eating disorder evaluation quesionnaire (EDE-Q) score
大体时间：1 year
|
Global score of the EDE-Q score will be used to assess eating disorder symptom severity |
1 year
|
|
Clinical impairment assessment questionnaire (CIA)
大体时间：1 year
|
CIA will be used to assess the degree of influence on every life of the patient |
1 year
|
|
ROME 4
大体时间：1 year
|
The patients will be assessed for the presence of ROME 4 criteria for functional gastrointestinal disorders including irritable bowel syndrome |
1 year
|
|
Irritable bowel syndrome symptome severity score (IBS-SSS)
大体时间：1 year
|
IBS-SSS is used to assess the intensity of IBS symptoms |
1 year
|
|
Gastrointestinal symptom rating scale for IBS (GSRS-IBS)
大体时间：1 year
|
GSRS-IBS will be used to assess the gastrointestinal symptoms of IBS |
1 year
|
|
Fecal microbiota composition
大体时间：1 week
|
The composition of gut microbiota will be assessed when the patient has started psychotherapy and has estaliblished regular eating. In addition, composition of gut microbiota will be assessed one week after fecal microbiota transplantation |
1 week
|
合作者和调查者
出版物和有用的链接
一般刊物
- Panah FM, Stoving RK, Sjogren M, Micali N, Maschek S, Reis KD, Mirsepasi-Lauridsen HC, Petersen AM, Nielsen DS, Helms M, Rasmussen MA, Barfod KK. Impact of a single fecal microbiome transplantation in adult women with anorexia nervosa: an open-label feasibility pilot trial. Nat Commun. 2026 Jan 14;17(1):1747. doi: 10.1038/s41467-026-68455-8.
- Frostad S. Are the Effects of Malnutrition on the Gut Microbiota-Brain Axis the Core Pathologies of Anorexia Nervosa? Microorganisms. 2022 Jul 24;10(8):1486. doi: 10.3390/microorganisms10081486.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 763219
- SDAM_FORS509460 (其他赠款/资助编号：Stiftelsen Dam)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Aggregated, deidentified data
IPD 共享时间框架
November 1st 2028 and for five years thereafter
IPD 共享访问标准
Contact with principal investigator
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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