Microbiome-mediated Weight, Anxiety, and Stress Dysregulation in Anorexia Nervosa

NCT03119272 | Completed

• 2 other identifiers: 15-21331R01MH105684-01A1
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  18 Months

• Stress level (as measured by the Perceived Stress Scale) as it relates to taxa (percentage abundance from phylum to the genus level).

  18 Months

Study Arms (2)

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.

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Inpatient population at Eating Disorders Unit (EDU) at UNC hospitals. Healthy controls pooled through UNC listserv.

You may qualify if:

• Anorexia nervosa patient receiving treatment

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 39569450 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples.

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Ian Carroll, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 18, 2017
• Study Start: April 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

US (1)