NCT02440087

Evaluation of the Dietary Supplement Refill Bypass to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery

Evaluation of the Dietary Supplement Refill Bypass Administered Sublingually to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery Type Gastric Bypass

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Refill France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes will be performed at 1 month, 3 months, 6 months and 9 months. This observational study is non-interventional, it does not change the usual care of patients who underwent a bariatric surgery. Data collection will be carried out during routine visits planned in the post-operation usual follow-up. The blood tests are part of the patient's usual care for his bariatric surgery. Surgeons will include patients for whom they have freely decided to use the dietary supplement Refill under the care of the treatment of obesity. The motivation of the patient and his commitment to the project is evaluated by the surgeon. The main objective is to evaluate the efficacy of the dietary supplement Refill. The primary endpoint is the reduction of iron deficiency.

Conditions

• Obesity
• Bariatric Surgery

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Refill Bypass	Dietary supplement

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-05-12
• Last updated: 2016-04-04

Locations

1 site across 1 country: France