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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Stein Frostad, MD PhD
- 電話番号：+47 95003257
- メール：stein.frostad@helse-bergen.no
研究連絡先のバックアップ
- 名前：Olivia B Helland, Master of Science
- メール：olivia.bysheim.helland@helse-bergen.no
研究場所
-
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Haugesund
-
Haugesund、Haugesund、ノルウェー、5535
- Haugalandet distriktspsykiatriske senter
-
コンタクト：
- Kenneth Eikeset, MD
- メール：kenneth.eikeset@helse-fonna.no
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Møre og Romsdal
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Ålesund、Møre og Romsdal、ノルウェー、6026
- Helse Møre og Romsdal
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コンタクト：
- Dag AL Hoff, MD PhD
- メール：Dag.Arne.Lihaug.Hoff@helse-mr.no
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Norway
-
Bergen、Norway、ノルウェー、5096
- Haukeland University Hospital in Helse Bergen
-
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Sola
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Stavanger、Sola、ノルウェー、4050
- Sola distriktspsykiatriske senter
-
コンタクト：
- Øystein Enger, Specialist Clinical Psychology
- メール：oystein.enger@sus.no
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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) |
|
実験的：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body mass index (BMI)
時間枠：1 year
|
Body mass index to assess weight development |
1 year
|
|
Eating disorder evaluation quesionnaire (EDE-Q) score
時間枠：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)
時間枠：1 year
|
CIA will be used to assess the degree of influence on every life of the patient |
1 year
|
|
ROME 4
時間枠：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)
時間枠：1 year
|
IBS-SSS is used to assess the intensity of IBS symptoms |
1 year
|
|
Gastrointestinal symptom rating scale for IBS (GSRS-IBS)
時間枠：1 year
|
GSRS-IBS will be used to assess the gastrointestinal symptoms of IBS |
1 year
|
|
Fecal microbiota composition
時間枠：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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 763219
- SDAM_FORS509460 (その他の助成金/資金番号：Stiftelsen Dam)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Aggregated, deidentified data
IPD 共有時間枠
November 1st 2028 and for five years thereafter
IPD 共有アクセス基準
Contact with principal investigator
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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