Anorexia NervosaMicrobiomeNCT03119272
Microbiome-mediated Weight, Anxiety, and Stress Dysregulation in Anorexia Nervosa
An observational study of Anorexia Nervosa, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this research study is to analyze the microorganisms residing in the gut of patients with anorexia nervosa. Research has begun to link changes in the intestinal microbiota with diseases such as inflammatory bowel disease (IBS), asthma, and obesity, but although some studies have investigated the… Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Inpatient population at Eating Disorders Unit (EDU) at UNC hospitals. Healthy controls pooled through UNC listserv.
Who may be able to join
- Anorexia nervosa patient receiving treatment
Who cannot join
- history of gastrointestinal tract surgery
- history of inflammatory bowel diseases (IBD)
- history of irritable bowel syndrome (IBS)
- history of celiac disease
- history of any other diagnosis that could explain chronic or recurring bowel symptoms
- treatment in the last two months with antibiotics, non-steroid anti-inflammatory agents, or steroids.
- eating disorders or other major psychiatric or medical issue (for healthy controls).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
The purpose of this research study is to analyze the microorganisms residing in the gut of patients with anorexia nervosa. Research has begun to link changes in the intestinal microbiota with diseases such as inflammatory bowel disease (IBS), asthma, and obesity, but although some studies have investigated the intestinal microbiota in overweight/obese individuals, very little is known about the intestinal microbiota in underweight individuals. The investigators aim to identify the enteric bacterial groups associated with adiposity, BMI, anxiety, and stress in patients with anorexia nervosa.
Read the detailed description
Anorexia nervosa (AN), a psychiatric disorder characterized by extreme weight dysregulation commonly presents with comorbid anxiety. Therapeutic renourishment in AN is based primarily on clinical opinion and guidelines, with a weak evidence base. Compelling data implicate the intestinal microbiota in the regulation of adiposity and behavior, providing a strong rationale for exploring the role of this complex microbial community in the emergence and maintenance of, and recovery from AN. The overarching goal is to understand the precise mechanism(s) by which intestinal bacteria contribute to dysregulation of adiposity, BMI, anxiety, and stress in patients with AN. The investigators hypothesize that intestinal microbiotas that arise from prolonged starvation contribute to increases in adiposity upon refeeding and to persistently elevated anxiety and stress in individuals with AN. To test the hypothesis the investigators propose 3 specific aims. In aim 1, the investigators will identify the enteric bacterial groups associated with adiposity, BMI, anxiety, and stress in AN patients. The investigators will characterize the intestinal microbiota in acutely low weight AN patients (T1), in the same patients following weight restoration (T2), and in healthy controls (HC) via high throughput sequencing of the 16S rRNA gene.
The investigators will compare the abundances of specific enteric taxa with adiposity, BMI and behavior (anxiety and stress) in this study population. In aim 2, The investigators will characterize the functional impact of the intestinal microbiota of AN patients on adiposity and BMI when transplanted into germ free (GF) mice. The investigators will transplant uncultured microbiotas from AN patients (at T1 and T2) and HC into GF mice and assess the impact of enteric microbes on adiposity. In aim 3, the investigators will characterize the functional impact of the intestinal microbiota of AN patients on anxiety and stress, and molecular biomarkers of these behaviors, when transplanted into GF mice. The investigators will transplant uncultured microbiotas from T1 AN patients and HC into GF mice and assess the impact of enteric microbes on anxiety and stress. GF mice gavaged with sterile phosphate buffer saline will be used as controls in aims 2 and 3. The proposed science is significant in pioneering the combination of large scale 16S rRNA gene sequencing-based studies of intestinal microbiotas in AN with exploration of their functional influence on adiposity and behavioral traits associated with AN. The results will provide direction on how best to test adjunct interventions for AN with pre-, pro-, anti-, or syn-biotics to enhance current approaches to therapeutic weight restoration and improve treatment outcome. The science is highly innovative as it will investigate an entirely novel factor in AN, the intestinal microbiota, and use a novel approach to identify enteric microbes that impact adiposity and behavior in this devastating illness. Additionally, the investigators will hope to study an entirely novel factor (namely, the intestinal microbiota) as a contributor to the underlying pathophysiology of AN.
- Conditions
- Anorexia Nervosa
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa Patients | Inpatient population at Eating Disorders Unit (EDU) at the University of North Carolina Neurosciences Hospital. Recruited upon intake into the unit. | |
| Age and Sex Matched Healthy Controls | University of North Carolina Psychiatry email listserv. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfect total fat as it relates to each taxa (percentage abundance from phylum to the genus level) and their association with weight.
The composition and diversity of the intestinal microbiota will be characterized and correlated with adiposity. The researchers will use a DXA scan to measure this.
Measured: 18 Months
Secondary outcomes (2)
Anxiety level (as measured by the State-Trait Anxiety Inventory) as it relates to each taxa (percentage abundance from phylum to the genus level).
The composition and diversity of the intestinal microbiota will be characterized and correlated with anxiety measures.The enteric bacterial groups will be measured via percentage abundance from phylum to the genus level. Anxiety will be measured by the State-Trait Anxiety Inventory (STAI). The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
Measured: 18 Months
Stress level (as measured by the Perceived Stress Scale) as it relates to taxa (percentage abundance from phylum to the genus level).
The composition and diversity of the intestinal microbiota will be characterized and correlated with anxiety and stress measures.The enteric bacterial groups will be measured via percentage abundance from phylum to the genus level. Stress will be measured by the Perceived Stress Scale (PSS). The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startApr 2016
- Primary completionOct 2020
- Study completionOct 2020
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.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ian Carroll, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119272
- Sponsor's protocol ID
- 15-2133
- Other IDs
- 1R01MH105684-01A1
- Acronym
- Microbiome
- Status last verified
- Oct 2020
- First submitted
- 4 Apr 2016
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Reed KK, Bulik-Sullivan EC, Qian Y, Javorsky E, Tarantino LM, Fodor AA, Steffen KJ, Wonderlich SA, Mehler PS, Bulik CM, Carroll IM. Using Bomb Calorimetry to Investigate Intestinal Energy Harvest in Anorexia Nervosa: Preliminary Findings on Stool Calorie Loss. Int J Eat Disord. 2025 Feb;58(2):440-445. doi: 10.1002/eat.24331. Epub 2024 Nov 21.
PubMed 39569450
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome-mediated Weight, Anxiety, and Stress Dysregulation in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03119272
- Acronym / sponsor ID
- Microbiome / 15-2133
- Conditions
- Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 18 Apr 2017 (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.
The purpose of this research study is to analyze the microorganisms residing in the gut of patients with anorexia nervosa. Research has begun to link changes in the intestinal microbiota with diseases such as inflammatory bowel disease (IBS), asthma, and obesity, but although some studies have investigated the intestinal microbiota in overweight/obese individuals, very little is known about the intestinal microbiota in underweight individuals. The investigators aim to identify the enteric bacterial groups associated with adiposity, BMI, anxiety, and stress in patients with anorexia nervosa.
Detailed description
Anorexia nervosa (AN), a psychiatric disorder characterized by extreme weight dysregulation commonly presents with comorbid anxiety. Therapeutic renourishment in AN is based primarily on clinical opinion and guidelines, with a weak evidence base. Compelling data implicate the intestinal microbiota in the regulation of adiposity and behavior, providing a strong rationale for exploring the role of this complex microbial community in the emergence and maintenance of, and recovery from AN. The overarching goal is to understand the precise mechanism(s) by which intestinal bacteria contribute to dysregulation of adiposity, BMI, anxiety, and stress in patients with AN. The investigators hypothesize that intestinal microbiotas that arise from prolonged starvation contribute to increases in adiposity upon refeeding and to persistently elevated anxiety and stress in individuals with AN. To test the hypothesis the investigators propose 3 specific aims. In aim 1, the investigators will identify the enteric bacterial groups associated with adiposity, BMI, anxiety, and stress in AN patients. The investigators will characterize the intestinal microbiota in acutely low weight AN patients (T1), in the same patients following weight restoration (T2), and in healthy controls (HC) via high throughput sequencing of the 16S rRNA gene.
The investigators will compare the abundances of specific enteric taxa with adiposity, BMI and behavior (anxiety and stress) in this study population. In aim 2, The investigators will characterize the functional impact of the intestinal microbiota of AN patients on adiposity and BMI when transplanted into germ free (GF) mice. The investigators will transplant uncultured microbiotas from AN patients (at T1 and T2) and HC into GF mice and assess the impact of enteric microbes on adiposity. In aim 3, the investigators will characterize the functional impact of the intestinal microbiota of AN patients on anxiety and stress, and molecular biomarkers of these behaviors, when transplanted into GF mice. The investigators will transplant uncultured microbiotas from T1 AN patients and HC into GF mice and assess the impact of enteric microbes on anxiety and stress. GF mice gavaged with sterile phosphate buffer saline will be used as controls in aims 2 and 3. The proposed science is significant in pioneering the combination of large scale 16S rRNA gene sequencing-based studies of intestinal microbiotas in AN with exploration of their functional influence on adiposity and behavioral traits associated with AN. The results will provide direction on how best to test adjunct interventions for AN with pre-, pro-, anti-, or syn-biotics to enhance current approaches to therapeutic weight restoration and improve treatment outcome. The science is highly innovative as it will investigate an entirely novel factor in AN, the intestinal microbiota, and use a novel approach to identify enteric microbes that impact adiposity and behavior in this devastating illness. Additionally, the investigators will hope to study an entirely novel factor (namely, the intestinal microbiota) as a contributor to the underlying pathophysiology of AN.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa Patients | – | –Inpatient population at Eating Disorders Unit (EDU) at the University of North Carolina Neurosciences Hospital. Recruited upon intake into the unit. |
| Age and Sex Matched Healthy Controls | – | –University of North Carolina Psychiatry email listserv. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Inpatient population at Eating Disorders Unit (EDU) at UNC hospitals. Healthy controls pooled through UNC listserv.
Key inclusion criteria (1 listed)
- Anorexia nervosa patient receiving treatment
Key exclusion criteria (7 listed)
- history of gastrointestinal tract surgery
- history of inflammatory bowel diseases (IBD)
- history of irritable bowel syndrome (IBS)
- history of celiac disease
- history of any other diagnosis that could explain chronic or recurring bowel symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perfect total fat as it relates to each taxa (percentage abundance from phylum to the genus level) and their association with weight.
Time frame: 18 Months
The composition and diversity of the intestinal microbiota will be characterized and correlated with adiposity. The researchers will use a DXA scan to measure this.
2 secondary outcomes
Anxiety level (as measured by the State-Trait Anxiety Inventory) as it relates to each taxa (percentage abundance from phylum to the genus level).
Time frame: 18 Months
Stress level (as measured by the Perceived Stress Scale) as it relates to taxa (percentage abundance from phylum to the genus level).
Time frame: 18 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Derived from this study: PubMed 39569450Reed KK, Bulik-Sullivan EC, Qian Y, Javorsky E, Tarantino LM, Fodor AA, Steffen KJ, Wonderlich SA, Mehler PS, Bulik CM, Carroll IM. Using Bomb Calorimetry to Investigate Intestinal Energy Harvest in Anorexia Nervosa: Preliminary Findings on Stool Calorie Loss. Int J Eat Disord. 2025 Feb;58(2):440-445. doi: 10.1002/eat.24331. Epub 2024 Nov 21.
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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. This study is not recruiting at the moment.
Ian Carroll, PhD principal investigator
University of North Carolina
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, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 23 Oct 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfect total fat as it relates to each taxa (percentage abundance from phylum to the genus level) and their association with weight. (time frame: 18 Months). 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 NCT03119272, 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 Oct 2020.