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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new ways to understand anorexia nervosa using a capsule called Vibrant. Researchers seek to determine if individuals with anorexia experience unusual "gut feelings" and how these might affect their health. Participants will receive either a special capsule that stimulates the stomach or a placebo capsule that does not. This trial may suit females aged 15 to 40 with a primary diagnosis of anorexia nervosa who have transitioned to a less acute treatment status. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new insights and treatments for anorexia nervosa.

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.

What prior data suggests that the Vibrant capsule is safe for use in this study?

Research shows that the Vibrant capsule is generally safe. Studies on its use for constipation found that patients tolerated it well. Participants reported few side effects, and those were mild. Independent committees reviewed these trials to ensure the capsule's safety. While more research is needed to understand its use for anorexia, current data for treating constipation suggests that the Vibrant capsule is very safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike other treatments for anorexia that primarily focus on psychological therapy or nutritional support, the Vibrant capsule offers a novel approach by using gastric stimulation. This capsule is unique because it delivers mechanical stimulation directly to the stomach, which may enhance appetite and digestion without the need for drugs or invasive procedures. Researchers are excited about this treatment as it targets the digestive system directly, potentially offering a new avenue for managing anorexia that bypasses the need for traditional medication or therapy.

What evidence suggests that the Vibrant capsule might be an effective treatment for anorexia?

Research has shown that the Vibrant capsule, which participants in this trial may receive, offers promising results for managing appetite and digestion issues. Animal studies found that the capsule can lower ghrelin levels, a hormone that triggers hunger. Animals that received the capsule consumed 40% less food than those without it. This suggests the capsule might help control appetite by activating stomach sensors that signal the brain to feel less hungry. Importantly, the capsule does not appear to affect the digestive system's movement of food, as animals passed it without problems. While these results primarily come from animal studies, they provide a basis for exploring the capsule's potential in treating anorexia nervosa by affecting gut sensations. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. nibib.nih.gov nibib.nih.gov/news-events/newsroom/how-vibrating-capsule-could-help-curb-obesity

How a vibrating capsule could help curb obesity Blood samples revealed that the treated animals experienced a marked reduction in the hunger hormone ghrelin compared to the untreated animals.

2. science.org science.org/doi/10.1126/sciadv.adj3003

A vibrating ingestible bioelectronic stimulator modulates ... In this study, we developed a new luminal stimulation modality to specifically activate these gastric stretch receptors to elicit a vagal afferent response.

3. news.mit.edu news.mit.edu/2023/engineers-develop-vibrating-ingestible-capsule-1222

Engineers develop a vibrating, ingestible capsule that ... They found that when the pill was activated for about 20 minutes, before the animals were offered food, they consumed 40 percent less, on ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10370054/

A Vibrating Ingestible BioElectronic Stimulator Modulates ... These data suggest that VIBES does not have any negative impact on motility. In all trials, animals were able to pass the pill without ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/75/NCT04458675/Prot_SAP_000.pdf

Vibrant Ltd. Evidence of effectiveness of the capsule was indicated by reduced defecation time with the vibrating capsule ... results and all data derived from the study.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01306448

Safety Evaluation of the Vibrating Capsule (Vibrant) Study Overview. The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals. ...

7. thelancet.com thelancet.com/cms/10.1016/j.eclinm.2022.101407/attachment/d623b50c-814a-4c2e-ad92-53f515eecc02/mmc1.pdf

Protocol Efficacy and safety of vibrating capsule for ... Perform source data verification and review. Complete a written monitoring report after each visit. An independent Data and safety monitoring committee (DSMC).

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40059867/

The Vibrating Capsule: Safety and Tolerability in Patients ... The Vibrating Capsule, a first in class treatment for CIC was found to be safe and well tolerated by patients in clinical trials.

9. ovid.com ovid.com/journals/negmot/fulltext/10.1111/nmo.12485~safety-and-efficacy-of-the-vibrating-capsule-an-innovative

Safety and efficacy of the vibrating capsule, an... The Vibrant Capsule is safe and potentially effective in the treatment of constipation, justifying randomized controlled studies. We assessed the safety and ...

10. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03031301/a-study-to-assess-the-efficacy-and-safety-of-the-vibrant-capsule-administered-5-times-per-week

A Study to Assess the Efficacy and Safety of the Vibrant ... The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the ...