Clinical trial NCT03517345: The Metabolic Effects of Prebiotic Supplementation After Roux-en-Y Gastric Bypass Surgery
Official title: Investigating the Effects of Prebiotic Supplementation on Metabolic Effects of Roux-en-Y Gastric Bypass Surgery: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Keywords: Bariatric surgery
Prebiotics
gut microbiota
GLP-1
PYY
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, it is aimed to evaluate whether the addition of prebiotics to patients' post-operative diets increases Roux-en-Y Gastric Bypass surgery effects. Half of the participants were randomized prebiotic with conventional yogurt, while the other half were randomized only conventional yogurt as a snack

Detailed description: Following bariatric surgery, positive alterations are observed in gut microbiota, intestinal peptides, and inflammatory cytokines. Previous studies demonstrate that prebiotic use alone in a tolerable dose (which is 10 g/day) among obese, overweight, or diabetic individuals accelerated the weight loss by reducing hunger and food intake. Furthermore, it could also contribute to the improvement of glucose homeostasis by increase postprandial PYY and GLP-1 levels. Prebiotics feeds healthy intestinal bacteria and enhances their positive effects. The present positive effects appear with SCFAs that stimulates PYY and GLP-1 release and produced by fermentation of prebiotics by bacteria. From this point forth, it was hypothesized that post-operative pre-probiotic usage may enhance the effects of Roux-en-Y Gastric Bypass (RYGB). In addition, administration of pre-probiotics following RYGB may be considered as a simple and cheap treatment support, especially for protecting patients with poor medicine compliance against nutritional deficiencies, as well as for diabetic patients whose glucose regulations deteriorate in the long term, and for those who regain weight.

With the result that the effects of prebiotic supplementation on metabolic results of RYGB surgery in this prospective, randomized, controlled study with a duration of 24 weeks were tested.

Eligibility criteria: Inclusion Criteria:

* BMI \>40kg/m2; perform of other types of bariatric surgery except gastric bypass (i.e. sleeve gastrectomy, adjustable gastric band)

Exclusion Criteria: I

* Administration of antibiotics (other than 1 g ampicillin-sulbactam one hour before surgery), the presence of chronic gastrointestinal, liver or kidney diseases and malignancy.

Primary outcomes:
measure: Plasma GLP-1 levels changes
timeFrame: 6 months
measure: Plasma PYY levels changes
timeFrame: 6 months
Secondary outcomes:
measure: Appetite regulation
timeFrame: 6 months
Other outcomes:
measure: weight changes
timeFrame: 6 months
measure: fat mass changes
timeFrame: 6 months
measure: fat free mass changes
timeFrame: 6 months
measure: excess weight loss changes
timeFrame: 6 months
measure: serum glucose changes
timeFrame: 6 months
measure: serum insulin changes
timeFrame: 6 months
Locations:
Study officials:
References:
citation: Calikoglu F, Barbaros U, Uzum AK, Tutuncu Y, Satman I. The Metabolic Effects of Pre-probiotic Supplementation After Roux-en-Y Gastric Bypass (RYGB) Surgery: a Prospective, Randomized Controlled Study. Obes Surg. 2021 Jan;31(1):215-223. doi: 10.1007/s11695-020-04894-6. Epub 2020 Aug 15.