Ulcerative Colitis Chronic MildNCT06214078
Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis
A study testing nicotinamide mononucleotide in people with Ulcerative Colitis Chronic Mild, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis Chronic Mild
- What is being tested?
- nicotinamide mononucleotide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Wang Xiaoyan, Doctor, +8613974889301, wxy20011@163.com
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial of Nicotinamide Mononucleotide in the Treatment of Mild Ulcerative Colitis
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
- Being tested
- nicotinamide mononucleotide, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotinamide mononucleotideDietary 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.
placeboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: nicotinamide mononucleotide |
| placebo group | Placebo comparator | Patients in this group will receive 1 placebo capsule orally twice daily for 8 weeks. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 8 weeks
clinical remission rate
It was defined as modified Mayo score ≤2 and no single subscore > 1.
Measured: 8 weeks
Endoscopic remission rate
Endoscopic remission was defined as Mayo endoscopic score (MES) =0 or UCEIS score ≤1.
Measured: 8 weeks
Histologic remission rate after 8 weeks of intervention
Histological remission: Geboes index score < 2.0.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis Chronic MildStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoyan Wang, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214078
- Sponsor's protocol ID
- 2024-NMN-XY3
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial of Nicotinamide Mononucleotide in the Treatment of Mild Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06214078
- Acronym / sponsor ID
- 2024-NMN-XY3
- Conditions
- Ulcerative Colitis Chronic Mild
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMN group | Experimental | Dietary Supplement: nicotinamide mononucleotidePatients 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 | Other: placeboPatients in this group will receive 1 placebo capsule orally twice daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nicotinamide mononucleotideNicotinamide 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. | Dietary supplement | NMN group |
| placeboThe 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. | Other | placebo group |
Primary outcome
Clinical response rate
Time frame: 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.
4 secondary outcomes
Biomarker target attainment rate
Time frame: 8 weeks
clinical remission rate
Time frame: 8 weeks
Endoscopic remission rate
Time frame: 8 weeks
Histologic remission rate after 8 weeks of intervention
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No. Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyan Wang principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nicotinamide mononucleotide in people with Ulcerative Colitis Chronic Mild, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Wang (+8673188618011, 912877437@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.