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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
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.
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.
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGClinical 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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
clinical remission rate
It was defined as modified Mayo score ≤2 and no single subscore \> 1.
Time frame: 8 weeks
Endoscopic remission rate
Endoscopic remission was defined as Mayo endoscopic score (MES) =0 or UCEIS score ≤1.
Time frame: 8 weeks
Histologic remission rate after 8 weeks of intervention
Histological remission: Geboes index score \< 2.0.
Time frame: 8 weeks
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