Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis

NCT ID: NCT06214078

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-07-30

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.

Conditions

Ulcerative Colitis Chronic Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

nicotinamide mononucleotide

Intervention Type: DIETARY_SUPPLEMENT

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 group

Patients in this group will receive 1 placebo capsule orally twice daily for 8 weeks.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoyan Wang

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital of Central South University

Locations

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyan Wang

Role: CONTACT

912877437@qq.com

+8673188618011

Facility Contacts

Wang Xiaoyan, Doctor

Role: primary

wxy20011@163.com

+8613974889301

Other Identifiers

2024-NMN-XY3

Identifier Type: -

Identifier Source: org_study_id