Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis Chronic Mild
• Interventions: Other: placebo; Dietary Supplement: nicotinamide mononucleotide

• Registration Number: NCT06214078
• Lead Sponsor: The Third Xiangya Hospital of Central South University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Study Start: 2024-02-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	placebo	Patients in this group will receive 1 placebo capsule orally twice daily for 8 weeks.
NMN group	nicotinamide mononucleotide	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.

Primary Outcome Measures

Name	Time	Method
Clinical response rate	8 weeks	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 Outcome Measures

Name	Time	Method
Endoscopic remission rate	8 weeks	Endoscopic remission was defined as Mayo endoscopic score (MES) =0 or UCEIS score ≤1.
Histologic remission rate after 8 weeks of intervention	8 weeks	Histological remission: Geboes index score \< 2.0.
Biomarker target attainment rate	8 weeks	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	8 weeks	It was defined as modified Mayo score ≤2 and no single subscore \> 1.

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China