Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota

Sponsor
Haukeland University Hospital
Study ID
NCT07574892
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psychotherapy as usual combined with single dose normal gut microbiota — BIOLOGICAL
    Psychotherapy treatment as usual (TAU) combined with single dose normal fecal microbiota (FMT) will be compared with TAU
  • Psychotherapy treatment as usual (TAU) — OTHER
    Psychotherapy treatment as usual (TAU)

Study Details

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.

Key Dates

First listed
May 8, 2026
Start date
Jun 1, 2026
Status verified
Feb 2026
Primary completion
Nov 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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)
  • Experimental: 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)

Primary Outcome Measure

Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation [ Time Frame: 1 year ]

Central Contacts

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