Vibrant Capsule for Anorexia

Overseen By Sahib Khalsa, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Laureate Institute for Brain Research, Inc.

Must not be taking: Psychotropics, NSAIDs, Opiates, others

Disqualifiers: Psychiatric disorder, Suicidal ideation, Pregnancy, others

Compensation: Varies

Number of Visits: 8

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Anorexia nervosa (AN) has among the highest mortality rate of any psychiatric illness, yet we have a poor understanding of the biological causes of this disorder. In this study, we use a novel mechanosensory intervention to examine the basic question of whether individuals with AN have abnormal "gut sensations" and whether such indicators are associated with adverse consequences from the disorder.

Will I have to stop taking my current medications?

The trial requires that participants with anorexia nervosa must be on a stable dose of medication for at least one week before joining. However, if you are taking medications that affect intestinal movement or certain other medications, you may need to stop those to participate.

How does the Vibrant capsule treatment for anorexia differ from other treatments?

The Vibrant capsule treatment for anorexia is unique because it may involve a novel mechanism or administration route compared to traditional treatments like ghrelin, which is administered intravenously to stimulate appetite. While ghrelin increases hunger and food intake, the Vibrant capsule could offer a different approach, potentially involving oral administration or other innovative methods. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for females aged 15-40 with anorexia nervosa, a BMI ≥ 18.5, and stable on current medications. Participants must be able to walk, have a smartphone with data, speak English, use birth control if of childbearing age, and provide consent. Exclusions include psychiatric disorders other than AN, certain medication use (affecting gut motility), significant GI disorders or surgeries affecting the gut's structure/function.

Inclusion Criteria

HC Inclusion criteria: English proficiency

AN Inclusion criteria: Body mass index ≥ 18.5

AN Inclusion criteria: Possession of a smartphone with data plan

Exclusion Criteria

HC Exclusion criteria: Active cutting or skin lacerating behaviors

AN Exclusion criteria: Bradycardia less than 40 beats per minute

AN Exclusion criteria: Regular use of specific medications or procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including interoceptive learning rate, precision, electrogastrogram, and evoked response potential measurements

1 week

1 visit (in-person)

Intervention

Participants receive either gastric stimulation via the Vibrant capsule or a placebo capsule

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for illness status including relapse, remission, or recovery at 1 month, 3 months, and 6 months

6 months

3 visits (in-person)

Treatment Details

Interventions

• Vibrant capsule

Trial Overview The study tests whether a novel device called the Vibrant capsule can detect abnormal 'gut sensations' in individuals with anorexia nervosa and if these sensations are linked to negative outcomes of the disorder.

Participant Groups

Group I: Capsule stimulation Experimental Treatment 1 Intervention

Participants in this arm will receive gastric stimulation via the Vibrant capsule

Group II: Placebo stimulation Placebo Group 1 Intervention

Participants in this arm will receive no gastric stimulation via a placebo capsule

Who Is Running the Clinical Trial?

Laureate Institute for Brain Research, Inc.

Lead Sponsor

Trials

53

Recruited

5,400+

Findings from Research

Adipose tissue acts as an endocrine organ, secreting adipocytokines like leptin and adiponectin, which play crucial roles in regulating metabolism, energy balance, and immune function, with significant implications for conditions like obesity and anorexia nervosa.

In obesity, there is an increase in leptin and resistin levels alongside a decrease in adiponectin, while anorexia nervosa shows the opposite pattern, indicating that plasma levels of these adipocytokines can serve as important markers for nutritional status in affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adipocytokines: potential biomarkers for childhood obesity and anorexia nervosa]. Leoni, MC., Pizzo, D., Marchi, A.[2015]

A pilot study involving five patients with restricting-type anorexia nervosa (AN) showed that intravenous infusion of ghrelin can potentially stimulate appetite and increase food intake, addressing malnutrition-induced gastrointestinal dysfunction.

Ghrelin, as an orexigenic hormone, presents a promising therapeutic option for patients with AN who are motivated to gain weight but struggle to do so due to their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic potential of ghrelin in restricting-type anorexia nervosa. Hotta, M., Ohwada, R., Akamizu, T., et al.[2018]

In a study of 30 adolescent inpatients with anorexia nervosa (AN) and 30 healthy controls, visfatin levels were found to be significantly lower in the acute phase of AN and did not normalize after partial weight recovery, suggesting its potential role as a biomarker for the condition.

A positive correlation was observed between visfatin levels and obsessive-compulsive symptoms in patients after partial weight recovery, indicating that visfatin may be involved in the non-homeostatic regulation of food intake and warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omentin and visfatin in adolescent inpatients with anorexia nervosa; association with symptoms. Tyszkiewicz-Nwafor, M., Dutkiewicz, A., Paszynska, E., et al.[2021]

Ghrelin infusion in five female patients with anorexia nervosa significantly improved gastrointestinal symptoms and increased hunger sensation, leading to a 12-36% increase in daily energy intake during treatment.

The treatment was safe, with no serious adverse effects reported, suggesting that ghrelin may have therapeutic potential for addressing appetite loss in anorexia nervosa patients, despite the study's limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ghrelin increases hunger and food intake in patients with restricting-type anorexia nervosa: a pilot study. Hotta, M., Ohwada, R., Akamizu, T., et al.[2019]

In a study involving 22 women with anorexia nervosa, the ghrelin agonist relamorelin significantly reduced gastric emptying time compared to placebo, indicating its potential to improve digestive function.

After 4 weeks of treatment, there was a trend toward weight gain in participants taking relamorelin (0.86 kg) compared to those on placebo (0.04 kg), suggesting it may help with weight restoration in anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment With a Ghrelin Agonist in Outpatient Women With Anorexia Nervosa: A Randomized Clinical Trial. Fazeli, PK., Lawson, EA., Faje, AT., et al.[2020]

References

1. Italy pubmed.ncbi.nlm.nih.gov

[Adipocytokines: potential biomarkers for childhood obesity and anorexia nervosa]. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Therapeutic potential of ghrelin in restricting-type anorexia nervosa. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Omentin and visfatin in adolescent inpatients with anorexia nervosa; association with symptoms. [2021]

4. Japan pubmed.ncbi.nlm.nih.gov

Ghrelin increases hunger and food intake in patients with restricting-type anorexia nervosa: a pilot study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment With a Ghrelin Agonist in Outpatient Women With Anorexia Nervosa: A Randomized Clinical Trial. [2020]