NCT04561284: CARMA

Carbohydrate-induced Resilience of the Gut Microbiome After Antibiotics Use

Completed NA Last updated 28 December 2022

What this trial tests

NA trial testing Indigestible fiber (classified) in Overweight and Obesity in 39 participants. Completed in 21 October 2022.

Timeline

1 November 2020

Primary endpoint
21 October 2022

21 October 2022

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	39
Start date	1 November 2020
Primary completion	21 October 2022
Estimated completion	21 October 2022
Sites	1 location across Netherlands

Drugs / interventions tested

• Indigestible fiber (classified)
• Placebo

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →
• Insulin Resistance — all drugs for Insulin Resistance →
• Dysbiosis — all drugs for Dysbiosis →

Sponsor

Maastricht University Medical Center

Who can join

Adults 20 to 65, any sex, with Overweight and Obesity or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The gut microbiome is a complex ecosystem with a wide range of functions, and it is thought that it can influence multiple processes in the human body. In turn, the composition and activity of the gut microbiome is affected by many factors as well.

Antibiotics can be very effective in treating bacterial infections, but they are also associated with detrimental health effects. Previous studies have already shown that antibiotics disturb the human gut microbiome composition by destroying commensal bacteria. As it is well known that the microbiome influences host metabolism, perturbation of the healthy microbiome (dysbiosis) is thought to be disease causing.

Prebiotics, on the other hand, are beneficial for the gut microbiome. These so-called indigestible fibers are naturally present in our foods, but cannot be metabolised by the human body. Many bacteria in the human gut are able to ferment these fibers and they subsequently produce beneficial products for the rest of the body. Besides this, fiber intake stimulates growth of commensal bacteria in the human gut.

Although it has become increasingly clear that prebiotics have a beneficial effect on the gut microbiome and general health, it is still unclear to which extent the beneficial effects of prebiotics supplementation occur after the gut microbiome is disturbed by antibiotics. We hypothesize that prebiotic supplementation after antibiotics use will improve restoration of the gut microbiome to a healthy state compared to placebo.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Distinct gut microbiota and metabolome features of tissue-specific insulin resistance in overweight and obesity.
   Jardon KM, Umanets A, Gijbels A, Trouwborst I, et al · · 2025 · cited 7× · PMID 40336254 · DOI 10.1080/19490976.2025.2501185
2. 2'-Fucosyllactose supplementation results in a transient improvement in gut microbial resilience after vancomycin use in adults with overweight or obesity: a randomized, double-blind, placebo-controlled intervention.
   Vliex LMM, Barnett D, Monzel E, Nauta A, et al · · 2025 · cited 1× · PMID 41243448 · DOI 10.1080/19490976.2025.2580693