Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis

NCT06214078 | Unknown

• 1 other identifier: 2024-NMN-XY3
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Biomarker target attainment rate

  8 weeks

• clinical remission rate

  8 weeks

• Endoscopic remission rate

  8 weeks

• Histologic remission rate after 8 weeks of intervention

  8 weeks

Study Arms (2)

NMN group

EXPERIMENTAL

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

placebo group

PLACEBO COMPARATOR

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

Other: placebo

Interventions

nicotinamide mononucleotide 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.

NMN group

placebo 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.

placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, ≤75 years old;
• Clinical diagnosis of mild active UC patients, the diagnosis standard reference inflammatory bowel disease diagnosis and treatment of the consensus of opinion 2018.
• Agreed to participate in this study, and sign the informed consent.

You may not qualify if:

• Patients with ALT or AST more than 2 times the upper limit of normal, TBIL more than 2 times the upper limit of normal;
• The creatinine clearance patients less than 60 ml/min.
• The intestines or other parts have severely active infection patients need to use antibiotics or antiviral drugs;
• Crohn's disease and intestinal tuberculosis and other chronic intestinal infectious disease, intestinal malignant tumor patients;
• Pregnancy and lactation women;
• People with diabetes or screening period more than 7.0 tendency for fasting glucose/L or glycosylated hemoglobin exceed 6.5%;
• With serious mental illness, such as drugs and alcohol can't cooperate with the patients;
• Participated in any other clinical investigator within 1 month before the screening period;
• The researchers determine any other disease or condition is not suitable for patients participate in the study.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Interventions

Nicotinamide Mononucleotide

Intervention Hierarchy (Ancestors)

Ribonucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Xiaoyan Wang

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Wang

CONTACT

+8673188618011; 912877437@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: February 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: July 30, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)