Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis

NCTNCT06214078Other id2024-NMN-XY3

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Overview

Status: Status unknown
Phase: Not applicable
Enrollment: 48 participants (estimated)
Sponsor: The Third Xiangya Hospital of Central South University · Other
Design: Randomized · Quadruple masking
Countries: 1 country
China
Start: 1 Feb 2024 (estimated)
Primary completion: 1 Mar 2025 (estimated)
Completion: 30 Jul 2025 (estimated)
First posted: 19 Jan 2024
Last update posted: 19 Jan 2024
Conditions: Ulcerative Colitis Chronic Mild

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

N/A
Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis
NCT06214078
est. 1 Feb 2024 to est. 30 Jul 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of this clinical trial is to compare the safety and efficacy of nicotinamide mononucleotide (NMN) and placebo in patients with mild ulcerative colitis (UC). The main question it aims to answer is Whether NMN can alleviate the intestinal pathology of UC patients, so as to play a role in UC treatment or adjuvant therapy. Participants will be randomized into two groups, an NMN group or a placebo group. Patients in the NMN group were treated with NMN intervention for 8 weeks. The placebo group received a placebo intervention for 8 weeks.

Interventions

nicotinamide mononucleotideDietary supplement
placeboOther

Arms2

Experimental
NMN group
Patients in this group will take nicotinamide mononucleotide capsules orally twice daily for 8 weeks, one capsule per time, each actually containing 250mg of nicotinamide mononucleotide.
Placebo comparator
placebo group
Patients in this group will receive 1 placebo capsule orally twice daily for 8 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Clinical response rate
Time frame · 8 weeks
Registry description
Clinical response was defined according to STRIDE II as a reduction of at least 50% in Patient Reported Outcomes 2 (PRO2) rectal bleeding and stool frequency.

Secondary outcomes(4)

Biomarker target attainment rate
Time frame · 8 weeks
Registry description
The target of inflammatory biomarkers was defined as normal C-Reactive Protein (CRP) + Fecal Calprotectin (FC) decreased to 100-250 ug/g.
clinical remission rate
Time frame · 8 weeks
Registry description
It was defined as modified Mayo score ≤2 and no single subscore \> 1.
Endoscopic remission rate
Time frame · 8 weeks
Registry description
Endoscopic remission was defined as Mayo endoscopic score (MES) =0 or UCEIS score ≤1.
Histologic remission rate after 8 weeks of intervention
Time frame · 8 weeks
Registry description
Histological remission: Geboes index score \< 2.0.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Age ≥18 years old, ≤75 years old; 2. Clinical diagnosis of mild active UC patients, the diagnosis standard reference inflammatory bowel disease diagnosis and treatment of the consensus of opinion 2018. 3. Agreed to participate in this study, and sign the informed consent. Exclusion Criteria: 1. Patients with ALT or AST more than 2 times the upper limit of normal, TBIL more than 2 times the upper limit of normal; 2. The creatinine clearance patients less than 60 ml/min. 3. The intestines or other parts have severely active infection patients need to use antibiotics or antiviral drugs; 4. Crohn's disease and intestinal tuberculosis and other chronic intestinal infectious disease, intestinal malignant tumor patients; 5. Pregnancy and lactation women; 6. People with diabetes or screening period more than 7.0 tendency for fasting glucose/L or glycosylated hemoglobin exceed 6.5%; 7. With serious mental illness, such as drugs and alcohol can't cooperate with the patients; 8. Participated in any other clinical investigator within 1 month before the screening period; 9. The researchers determine any other disease or condition is not suitable for patients participate in the study.

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