Ulcerative Colitis Chronic Mild
Conditions
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.
Interventions
DIETARY_SUPPLEMENTnicotinamide 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.
OTHERplacebo
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.
Sponsors
The Third Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response rate | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker target attainment rate | 8 weeks | The target of inflammatory biomarkers was defined as normal C-Reactive Protein (CRP) + Fecal Calprotectin (FC) decreased to 100-250 ug/g. |
| clinical remission rate | 8 weeks | It was defined as modified Mayo score ≤2 and no single subscore \> 1. |
| Endoscopic remission rate | 8 weeks | Endoscopic remission was defined as Mayo endoscopic score (MES) =0 or UCEIS score ≤1. |
| Histologic remission rate after 8 weeks of intervention | 8 weeks | Histological remission: Geboes index score \< 2.0. |
Countries
China
Contacts
Primary ContactXiaoyan Wang
Outcome results
None listed