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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| placebo group | Placebo Comparator | Patients in this group will receive 1 placebo capsule orally twice daily for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan Wang | Contact | +8673188618011 | 912877437@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoyan Wang | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.
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| ID | Term |
|---|---|
| D009537 | Nicotinamide Mononucleotide |
| ID | Term |
|---|---|
| D012265 | Ribonucleotides |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| 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. |
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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 |