NCT05399316 (INLITE) is a NA clinical trial of Inulin in Gut Microbiota Dysbiosis and Nutrition, sponsored by Experimental and Clinical Research Center.

Who is sponsoring NCT05399316?

NCT05399316 is sponsored by Experimental and Clinical Research Center.

What drugs are being tested in NCT05399316?

Interventions in NCT05399316: Inulin, Maltodextrin.

What condition does NCT05399316 study?

NCT05399316 studies Gut Microbiota Dysbiosis and Nutrition.

Is NCT05399316 still recruiting?

NCT05399316 is currently completed. Last updated 2 May 2025.

Last reviewed 2025-05-02 · How we verify

NCT05399316: INLITE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Inulin and the Gut Microbiota in Healthy Adults

Completed NA Last updated 2 May 2025

What this trial tests

NA trial testing Inulin in Gut Microbiota Dysbiosis and Nutrition in 24 participants. Completed in 31 December 2022.

Timeline

15 June 2022

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Experimental and Clinical Research Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	24
Start date	15 June 2022
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across Germany

Drugs / interventions tested

Inulin — full drug profile →
Maltodextrin (MALTODEXTRIN) — full drug profile →

Conditions studied

Gut Microbiota Dysbiosis and Nutrition — all drugs for Gut Microbiota Dysbiosis and Nutrition →

Sponsor

Experimental and Clinical Research Center

Who can join

Adults 20 to 60, any sex, with Gut Microbiota Dysbiosis and Nutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study the effects of a fibre dietary supplement on the gut microbiome in healthy adults will be investigated. For this purpose, a 14-day dietary supplementation with inulin or placebo (maltodextrin) will be carried out in healthy adults. The main objective of the study is to investigate inulin-induced changes in gut bacterial composition, bacterial gene expression, bacterial metabolite production and associated immune system changes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Inulin

Trials testing the same drug.

NCT07537192 — Inulin-Spirulina Co-intervention for Insomnia Disorder · NA · not yet recruiting
NCT07525180 — Comparing Prebiotic Fiber Supplements for Gut Health and Digestive Comfort · NA · not yet recruiting
NCT06372249 — A Clinical Trial of Soluble Fiber for Asthma · Phase 2 · recruiting
NCT06866262 — Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell · Phase 1, PHASE2 · recruiting
NCT06607523 — The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05399316 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Experimental and Clinical Research Center
Last refreshed: 2 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05399316.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing