Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis

Ulcerative Colitis Chronic Mild Clinical Trial

Official title:

A Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial of Nicotinamide Mononucleotide in the Treatment of Mild Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214078
• Other study ID #: 2024-NMN-XY3
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: January 2024
• Source: The Third Xiangya Hospital of Central South University
• Contact: Xiaoyan Wang
• Phone: +8673188618011
• Email: 912877437[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 30, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis Chronic Mild

Intervention

Dietary Supplement:
• nicotinamide mononucleotide
Nicotinamide mononucleotide (NMN), a bioactive substance found in a variety of foods, is a precursor for the synthesis of nicotinamide adenine dinucleotide (NAD+). NAD+ plays a crucial role in a variety of biological processes including cell death, senescence, gene expression, neuroinflammation, and DNA repair.

Other:
• placebo
The placebo mimicked the appearance and properties of nicotinamide mononucleotide(NMN) enteric-coated capsules. The specifications, usage and dosage of placebo were the same as those of NMN.

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

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