Anorexia NervosaNORMANCT06144905
Norwegian Microbiota Study in Anorexia Nervosa
An observational study of Anorexia Nervosa and Mental Health Issue, run by Norwegian University of Life Sciences at 1 site in Norway.
Trial summary
Anorexia nervosa (AN) is a serious mental disorder occurring mainly in women. AN is characterized by severely restricted food-intake and subsequent low weight. The disease burden for the individual is high with medical complications and psychiatric comorbidities. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Anorexia Nervosa, Mental Health Issue, Microbiota
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- 24 Sep 2023to Sep 2043
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The female patients with anorexia nervosa (AN) are undergoing specialized nutritional rehabilitation treatment and will be recruited from five Norwegian specialized inpatient treatment units for eating disorders. The standard care treatment consists of a program of psychotherapy and nutritional rehabilitation to achieve normalization of food-intake and weight gain. Although the clinical strategy of AN treatment is standardized, both the psychotherapy and dietary advices are individualized. The dietary advice during standard care treatment is based on clinical experience, as specific guidelines are lacking. Diets are adapted to each individual in aspects of tolerability and preferences, but typically comprise a high-energy diets aiming for a weekly weight gain of 0.5-1.5 kilograms. Often enteral nutrition (i.e., tube feeding) is required. The control group will be aged-matched female subjects with normal weight - mildly overweight.
Who may be able to join
- Sex: Female
- Age: 16-50 years
- BMI: <18.5 kg/m2
- fulfilling ICD-10 criteria for AN
- currently referred to specialized inpatient nutritional treatment for AN
- able to understand the Norwegian questionnaires.
Show all 10Show fewer
- Sex: Female
- Age: 16-50 years
- BMI: >= 18.5 \& < 27
- able to understand the Norwegian questionnaires.
Who cannot join
- history of inflammatory bowel disease, celiac disease, or GI tract surgery;
- treatment with oral antibiotics the past two months
- high intake of probiotic supplements over the past two months.
- history of inflammatory bowel disease, celiac disease, or GI tract surgery;
- treatment with oral antibiotics the past two months
- high intake of probiotic supplements over the past two months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Norwegian University of Life Sciences
Ås, Ås, 1433
Siv Kjølsrud Bøhn, PhD, sivb@nmbu.no
Ida Heir Hovland, MSc, ida.heir.hovland@nmbu.no
About this study
Official title: Gut Microbiota Alterations in Anorexia Nervosa - Paving the Way for Personalized Prebiotic Treatment Strategies
Anorexia nervosa (AN) is a serious mental disorder occurring mainly in women. AN is characterized by severely restricted food-intake and subsequent low weight. The disease burden for the individual is high with medical complications and psychiatric comorbidities. Despite decades of research, there are large gaps in the understanding of the biological aspects of AN and lack of effective interventions. Current clinical treatment is associated with gastrointestinal problems, high rates of relapse and poor outcome causing long-term sickness absence and disability. During the COVID19 pandemic the prevalence and severity of AN has spiked. Therefore, there is great need of novel strategies for AN treatment, that can be easily implemented in the clinic without adding complexity to the standard care of treatment. During the resent years it has been proposed that mental disorders might be treated via manipulating the composition and function of the microbes that live in the gut (the microbiota) by adding or restricting fermentable nutrients (prebiotics) in the diet. However, in order to use prebiotics to treat the microbiota in AN patients, more knowledge is needed on how the AN microbiota is affected by the current standard care treatment. Whether prebiotics can be useful for normalizing AN microbiota remains to be established. The overall aim of the "Norwegian study of Microbiota in Anorexia Nervosa" (NORMA) is to join forces of researchers, clinical health care services and voluntary sector in a transdiciplinary approach to improve the understanding of the role of the gut microbiota in AN patients. The current project will include a clinical trial in AN patients and experimental studies to screen novel prebiotics for their ability to modify and normalize AN derived microbiota. The long-term goal of the project is to pave the way for a targeted and clinically feasible individualized treatment for better tolerable weight-restoration and improved health in AN patients.
- Being tested
- standard care treatment program
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard care treatment programOther
The standard care treatment consists of a program of psychotherapy and nutritional rehabilitation to achieve normalization of food-intake and weight gain.
| Study group | Role | What they receive |
|---|---|---|
| Anorexia nervosa (AN) group | Female in-patients with anorexia nervosa, age 16-50 years with BMI below 18.5 kg/m2. Receives: Other: standard care treatment program | |
| Heathy control (HC) group | Female healthy controls, age 16-50 with normal to mild overweight (18.5 ≤ BMI< 27 kg/m2). . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the fecal microbiota composition
Comparison of fecal microbial composition between the patients with anorexia nervosa and healthy controls. We will compare different indices of α-diversity - investigating both richness and evenness (e.g. observed number of OTUs, Chao1, Shannon-Wiener, Simpson, and PD whole tree) and different indices of β-diversity (e.g. binary Jaccard, Bray-Curtis, and weighted Unifrac). Also differences in bacterial abundances at various taxonomic levels (phylum, class, order, family, and genus) will be investigated.
Measured: Cross-sectional study with only one time point. For AN-group; the baseline sample is delivered during the last week before start of clinical treatment. ]
Change in the fecal microbiota composition in patients with anorexia nervosa during the standard care treatment at the clinics for eating disorder.
Mixed model analyses will be performed to assess whether the standard care treatment at the clinics for eating disorder induce changes in the fecal microbiota composition. Both diversity measures ( α-diversity and β-diversity) and bacterial abundances at various taxonomic levels (phylum, class, order, family, and genus) will be investigated.
Measured: One group time-series design. Samples will be taken at baseline (~one week before admission to the clinic) and at ~6 weeks and ~12 weeks.
Change in mental scores during standard care treatment at the clinics for eating disorder
Mixed model analyses will be performed to assess whether the standard care treatment at the clinics for eating disorder induce changes in mental scores. Effects of time will be investigated in the AN group only. Mental scores will be assessed using digital questionnaires.
Measured: One group time-series design. Data will be collected at baseline, at admission to the clinic and at ~6 weeks and ~12 weeks.
Change in gastrointestinal problems during standard care treatment at the clinics for eating disorder
Mixed model analyses will be performed to assess whether the standard care treatment at the clinics for eating disorder induce changes in gastrointestinal problems. Effects of time will be investigated in the AN group only. Scores for gastrointestinal problems will be assessed using digital questionnaires.
Measured: One group time-series design. Data will be collected at baseline, at admission to the clinic and at ~6 weeks and ~12 weeks.
Secondary outcomes (3)
Associations between microbiota measures (diversity and abundance of specific species), serum biomarkers, dietary charachteristics, gastrointestinal issues and mental issues.
Associations between multiple variables will be investigated in both AN group (at baseline, 6 weeks and 12 weeks) and HC group at baseline using unsupervised learning algorithm techniques such as Principal Component Analysis and hireachical clustering techniques. Microbiota is charachterized as described under outcome 1, serum biomarkers include standard clinical biomarkers and biomarkers of inflammation and microbiota relevant biomarkers. Data on dietary charachteristics, gastrointestinal issues and mental issues are obtained by digital questionnaires.
Measured: Cross-sectional study with only one time point. For AN-group; the baseline sample is delivered during the last week before start of clinical treatment. ]
Associations between baseline microbiota composition and changes in gastrointestinal complaints during the standard care treatment at the clinics for eating disorder.
Associations between microbiota measures at baseline and changes in gastrointestinal complaint sduring the standard care treatment at the clinics for eating disorder will be investigated by unsupervised learning algorithm techniques such as Principal Component Analysis and by applying hireachical clustering techniques on correlation measures. Microbiota will be charachterized as described under outcome 1, serum biomarkers include standard clinical biomarkers and biomarkers of inflammation and microbiota relevant biomarkers. Data on dietary charachteristics, gastrointestinal issues and mental issues are obtained by digital questionnaires.
Measured: One group time-series design. Samples, data will be obtained at baseline (~one week before admission to the clinic) and at ~6 weeks and ~12 weeks.
Associations between baseline microbiota composition and changes in mental scores during the standard care treatment at the clinics for eating disorder.
Associations between microbiota measures at baseline and changes in mental scores during the standard care treatment at the clinics for eating disorder will be investigated by unsupervised learning algorithm techniques such as Principal Component Analysis and by applying hireachical clustering techniques on correlation measures. Microbiota will be charachterized as described under outcome 1, serum biomarkers include standard clinical biomarkers and biomarkers of inflammation and microbiota relevant biomarkers. Data on dietary charachteristics, gastrointestinal issues and mental issues are obtained by digital questionnaires.
Measured: One group time-series design. Samples, data will be obtained at baseline (~one week before admission to the clinic) and at ~6 weeks and ~12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start24 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Life Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Helse Nord-Trøndelag HF, Haukeland University Hospital, Nordlandssykehuset HF, Modum Bad, Karolinska Institutet, The Eating disorder Association, Norway (SPISFO), Counseling on eating disorders, Norway (ROS)
- Responsible party
- Principal investigator, Siv K Bohn, Norwegian University of Life Sciences
- Investigators
- Siv K Bøhn, PhD, Principal investigator, Norwegian University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144905
- Sponsor's protocol ID
- 336239_KBM_SKB2023
- Acronym
- NORMA
- Status last verified
- May 2025
- First submitted
- 22 Sep 2023
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hovland IH, Bang L, Herfindal AM, Stromland SS, Spernes TB, Jahanshahi A, Otterdal KL, Arsenovic D, Aspholm TE, Vik Y, Storvik JHM, Carlsen MH, Ones ML, Alisauskiene R, Hansen K, Weider S, Samdal I, Dahl J, Reistad HT, Tromborg AS, Lindstad LJ, Birkeland S, Eriksen HT, Engeset J, Bulik CM, Westereng B, Carlsen H, Ro O, Bohn SK. The Norwegian Microbiota Study in Anorexia Nervosa (NORMA): Integrating a clinical trial with preclinical experiments-A study protocol. PLoS One. 2026 Mar 11;21(3):e0342275. doi: 10.1371/journal.pone.0342275. eCollection 2026.
PubMed 41811825
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota Alterations in Anorexia Nervosa - Paving the Way for Personalized Prebiotic Treatment Strategies
- ClinicalTrials.gov ID
- NCT06144905
- Acronym / sponsor ID
- NORMA / 336239_KBM_SKB2023
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Norwegian University of Life SciencesUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Helse Nord-Trøndelag HF, Haukeland University Hospital, Nordlandssykehuset HF, Modum Bad, Karolinska Institutet, The Eating disorder Association, Norway (SPISFO), Counseling on eating disorders, Norway (ROS)
- Study start
- 24 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2043 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anorexia nervosa (AN) is a serious mental disorder occurring mainly in women. AN is characterized by severely restricted food-intake and subsequent low weight. The disease burden for the individual is high with medical complications and psychiatric comorbidities. Despite decades of research, there are large gaps in the understanding of the biological aspects of AN and lack of effective interventions. Current clinical treatment is associated with gastrointestinal problems, high rates of relapse and poor outcome causing long-term sickness absence and disability. During the COVID19 pandemic the prevalence and severity of AN has spiked. Therefore, there is great need of novel strategies for AN treatment, that can be easily implemented in the clinic without adding complexity to the standard care of treatment. During the resent years it has been proposed that mental disorders might be treated via manipulating the composition and function of the microbes that live in the gut (the microbiota) by adding or restricting fermentable nutrients (prebiotics) in the diet. However, in order to use prebiotics to treat the microbiota in AN patients, more knowledge is needed on how the AN microbiota is affected by the current standard care treatment. Whether prebiotics can be useful for normalizing AN microbiota remains to be established. The overall aim of the "Norwegian study of Microbiota in Anorexia Nervosa" (NORMA) is to join forces of researchers, clinical health care services and voluntary sector in a transdiciplinary approach to improve the understanding of the role of the gut microbiota in AN patients. The current project will include a clinical trial in AN patients and experimental studies to screen novel prebiotics for their ability to modify and normalize AN derived microbiota. The long-term goal of the project is to pave the way for a targeted and clinically feasible individualized treatment for better tolerable weight-restoration and improved health in AN patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa (AN) group | – | Other: standard care treatment programFemale in-patients with anorexia nervosa, age 16-50 years with BMI below 18.5 kg/m2. |
| Heathy control (HC) group | – | –Female healthy controls, age 16-50 with normal to mild overweight (18.5 ≤ BMI< 27 kg/m2). . |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The female patients with anorexia nervosa (AN) are undergoing specialized nutritional rehabilitation treatment and will be recruited from five Norwegian specialized inpatient treatment units for eating disorders. The standard care treatment consists of a program of psychotherapy and nutritional rehabilitation to achieve normalization of food-intake and weight gain. Although the clinical strategy of AN treatment is standardized, both the psychotherapy and dietary advices are individualized. The dietary advice during standard care treatment is based on clinical experience, as specific guidelines are lacking. Diets are adapted to each individual in aspects of tolerability and preferences, but typically comprise a high-energy diets aiming for a weekly weight gain of 0.5-1.5 kilograms. Often enteral nutrition (i.e., tube feeding) is required. The control group will be aged-matched female subjects with normal weight - mildly overweight.
Key inclusion criteria (10 listed)
- Sex: Female
- Age: 16-50 years
- BMI: <18.5 kg/m2
- fulfilling ICD-10 criteria for AN
- currently referred to specialized inpatient nutritional treatment for AN
Key exclusion criteria (6 listed)
- history of inflammatory bowel disease, celiac disease, or GI tract surgery;
- treatment with oral antibiotics the past two months
- high intake of probiotic supplements over the past two months.
- history of inflammatory bowel disease, celiac disease, or GI tract surgery;
- treatment with oral antibiotics the past two months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard care treatment programThe standard care treatment consists of a program of psychotherapy and nutritional rehabilitation to achieve normalization of food-intake and weight gain. | Other | Anorexia nervosa (AN) group |
Primary outcome
Differences in the fecal microbiota composition
Time frame: Cross-sectional study with only one time point. For AN-group; the baseline sample is delivered during the last week before start of clinical treatment. ]
Comparison of fecal microbial composition between the patients with anorexia nervosa and healthy controls. We will compare different indices of α-diversity - investigating both richness and evenness (e.g. observed number of OTUs, Chao1, Shannon-Wiener, Simpson, and PD whole tree) and different indices of β-diversity (e.g. binary Jaccard, Bray-Curtis, and weighted Unifrac). Also differences in bacterial abundances at various taxonomic levels (phylum, class, order, family, and genus) will be investigated.
Change in the fecal microbiota composition in patients with anorexia nervosa during the standard care treatment at the clinics for eating disorder.
Time frame: One group time-series design. Samples will be taken at baseline (~one week before admission to the clinic) and at ~6 weeks and ~12 weeks.
Mixed model analyses will be performed to assess whether the standard care treatment at the clinics for eating disorder induce changes in the fecal microbiota composition. Both diversity measures ( α-diversity and β-diversity) and bacterial abundances at various taxonomic levels (phylum, class, order, family, and genus) will be investigated.
Change in mental scores during standard care treatment at the clinics for eating disorder
Time frame: One group time-series design. Data will be collected at baseline, at admission to the clinic and at ~6 weeks and ~12 weeks.
Mixed model analyses will be performed to assess whether the standard care treatment at the clinics for eating disorder induce changes in mental scores. Effects of time will be investigated in the AN group only. Mental scores will be assessed using digital questionnaires.
Change in gastrointestinal problems during standard care treatment at the clinics for eating disorder
Time frame: One group time-series design. Data will be collected at baseline, at admission to the clinic and at ~6 weeks and ~12 weeks.
Mixed model analyses will be performed to assess whether the standard care treatment at the clinics for eating disorder induce changes in gastrointestinal problems. Effects of time will be investigated in the AN group only. Scores for gastrointestinal problems will be assessed using digital questionnaires.
3 secondary outcomes
Associations between microbiota measures (diversity and abundance of specific species), serum biomarkers, dietary charachteristics, gastrointestinal issues and mental issues.
Time frame: Cross-sectional study with only one time point. For AN-group; the baseline sample is delivered during the last week before start of clinical treatment. ]
Associations between baseline microbiota composition and changes in gastrointestinal complaints during the standard care treatment at the clinics for eating disorder.
Time frame: One group time-series design. Samples, data will be obtained at baseline (~one week before admission to the clinic) and at ~6 weeks and ~12 weeks.
Associations between baseline microbiota composition and changes in mental scores during the standard care treatment at the clinics for eating disorder.
Time frame: One group time-series design. Samples, data will be obtained at baseline (~one week before admission to the clinic) and at ~6 weeks and ~12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Derived from this study: PubMed 41811825Hovland IH, Bang L, Herfindal AM, Stromland SS, Spernes TB, Jahanshahi A, Otterdal KL, Arsenovic D, Aspholm TE, Vik Y, Storvik JHM, Carlsen MH, Ones ML, Alisauskiene R, Hansen K, Weider S, Samdal I, Dahl J, Reistad HT, Tromborg AS, Lindstad LJ, Birkeland S, Eriksen HT, Engeset J, Bulik CM, Westereng B, Carlsen H, Ro O, Bohn SK. The Norwegian Microbiota Study in Anorexia Nervosa (NORMA): Integrating a clinical trial with preclinical experiments-A study protocol. PLoS One. 2026 Mar 11;21(3):e0342275. doi: 10.1371/journal.pone.0342275. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Siv K Bøhn, PhD principal investigator
Norwegian University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Mental Health Issue, run by Norwegian University of Life Sciences at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siv K Bøhn, PhD (+47 67232502, sivb@nmbu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the fecal microbiota composition (time frame: Cross-sectional study with only one time point. For AN-group; the baseline sample is delivered during the last week before start of clinical treatment. ]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.