Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis Chronic Mild
• Intervention / Treatment: Dietary supplement: nicotinamide mononucleotide; Other: placebo

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoyan Wang; Phone Number: +8673188618011; Email: 912877437@qq.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • The third xiangya hospital of Central South University
      • Contact: Wang Xiaoyan, Doctor; Phone Number: +8613974889301; Email: wxy20011@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Placebo Comparator: placebo group; Patients in this group will receive 1 placebo capsule orally twice daily for 8 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
clinical remission rate	It was defined as modified Mayo score ≤2 and no single subscore > 1.	8 weeks
Endoscopic remission rate	Endoscopic remission was defined as Mayo endoscopic score (MES) =0 or UCEIS score ≤1.	8 weeks
Histologic remission rate after 8 weeks of intervention	Histological remission: Geboes index score < 2.0.	8 weeks

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University
• Investigators: Principal Investigator: Xiaoyan Wang, The third xiangya hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: 2024-NMN-XY3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No