Intragastric Injections of Botox for the Treatment of Obesity

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. If such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run.

There are now several pilot studies documenting that intragastric treatment with botulinum toxin A (BTA) can be effective, although the treatment perspective is short and do not include repeated injections. However, they demonstrate that BTA-injections are safe for the patient. The treatment is administered by endoscopy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Collaborator: St. Olavs Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• BMI > 35

Exclusion Criteria:

• Known hypersensitivity to medication

• Neuro muscular disease

• Dysphagia

• Tendency for aspiration

• Ulcus

• Use of aminoglycoside antibiotics and/or spectinomycin lately

• Previous side effects of botox injections

• Previous bariatric surgery

• Previous cancer in GI-tract

• Other obesity treatment last 12 months

• Severe eating disorder

• Hypothyroidism

• Pregnancy/brest feeding

• Reduced competence to consent