ColitisPhase 2/3NCT07047339
Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis
A Phase 2/3 study testing Probiotics 6600 in people with Colitis and IBD (Inflammatory Bowel Disease), run by Changhai Hospital at 1 site in China.
Trial summary
This study was conducted in two phases. In Phase I, 40 UC participants, 40 CD participants, and 40 colitis participants were randomly assigned in a 1:1 ratio to the experimental group and the control group, respectively. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colitis, IBD (Inflammatory Bowel Disease), Probiotic Intervention
- What is being tested?
- Probiotics 6600
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Ulcerative colitis (UC) : met the clinical diagnostic criteria of UC "Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi 'an)", and modified Mayo score ≥4 points;
- Crohn's disease (CD) : met the clinical diagnostic criteria of CD "Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou)", and CDAI score ≥220;
- Colitis: clinical diagnosis of colitis and modified SCCAI score ≥3; 3.
- The age of signing the informed consent form was from 18 to 75 years old (including the cut-off value, male and female were not limited);
- Complete medical history;
- From the time of informed consent until 3 months after the last dose of dose, the participant committed to not having any plans to have children or to have any plans to donate sperm or eggs, and to voluntarily use non-pharmacologic contraception;
- Fully understand the content, process and possible adverse reactions of the trial, voluntarily participate in the trial, and sign the informed consent.
Who cannot join
- Taking prebiotics or probiotics in the past 2 weeks or allergic to intervention preparations;
- Short bowel syndrome, abdominal abscess, toxic megacolon, intestinal perforation, active fistula of digestive tract, severe intestinal stenosis with obstructive symptoms, suspected intestinal obstruction, total colectomy;
- Other autoimmune diseases, hematological diseases, tumors, acute infections, severe hepatic and renal insufficiency (ALT>2 times the upper limit of normal), severe diseases such as neutropenia, heart failure, organic heart disease, viral hepatitis B, liver cirrhosis, renal impairment (serum creatinine > 2mg/dL or 177mmol/L), AIDS And mental disorders;
- History of psychoactive substance abuse;
- A history of drug or other dependent substance abuse, or heavy alcohol consumption in the last 2 weeks (i.e. 28 standard units per week for men and 21 standard units per week for women (1 standard unit contains 14g of alcohol, such as 360mL of beer or 25mL of 40% spirits or 150mL of wine); Heavy drinkers during the trial;
- Pregnant or breastfeeding women, or planning to become pregnant in the next 6 months;
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- Nervous system diseases such as Alzheimer's disease, stroke, Parkinson's disease;
- Participated in other clinical trials within the past 6 months;
- Incomplete medical record information (including gender, age, diagnostic information, colonoscopy results, pathological diagnosis results and other demographic data, etc.);
- Other investigators deemed ineligible for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai
Zhaoshen Li, Ph.D., +86 (021)-31161236, li.zhaoshen@hotmail.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis
This study was conducted in two phases. In Phase I, 40 UC participants, 40 CD participants, and 40 colitis participants were randomly assigned in a 1:1 ratio to the experimental group and the control group, respectively. The study included a screening period (1 week), a double-blind treatment period (24 weeks), an exit examination (1 day), and a safety follow-up period (4 weeks). After providing informed consent, participants who met the inclusion criteria and those who did not meet the exclusion criteria were randomly assigned, in a 1:1 ratio, to receive either the trial (probiotic 6600 capsules) or the control group (placebo). The clinical remission rate (SCCAI score ≤2 and no single subscore >1) after 24 weeks of treatment was calculated. Mayo score ≤2 and no single subscore >1; CDAI score ≤2 and no single subscore >1) were used as the primary efficacy index.
- Being tested
- Probiotics 6600, Placebo
- Medical subject headings
- Colitis, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics 6600Drug
As the core commensal bacteria of human body, probiotic 6600 has a unique ability to synthesize adhesins and exopolysaccharides. The intestinal protective effect is mediated by the following mechanisms: (1) regulation of Treg/Th17 balance by producing short-chain fatty acids (SCFAs); (2) activation of TLR2/MyD88 pathway inhibits NF-κB inflammatory cascade; (3) Upregulation of zonula occludens-1 enhances intestinal barrier function. Notably, this strain specifically metabolized arabinoxylan to produce the anti-inflammatory metabolite indole lactate, which has important therapeutic value in the colitis microenvironment.
Probiotic 6600 capsules are enteric capsules (containing probiotic 6600 10^11 CFU/ capsule), taken orally twice a day (after meals in the morning and evening), one capsule each time, and taken with warm water. The drug was stored at 2-8℃.
PlaceboDrug
The placebo capsules were also enteric-coated capsules, and were taken orally twice a day (morning and evening after meals), one capsule each time, with warm water.
| Study group | Role | What they receive |
|---|---|---|
| UC control group | Placebo comparator | Patients diagnosed with ulcerative colitis (UC) were given one tablet of placebo twice daily (morning and evening after meals) with warm water. Receives: Drug: Placebo |
| UC experimental group | Experimental | Patients diagnosed with ulcerative colitis (UC) were given probiotics 6600 orally twice daily (morning and evening after meals), one tablet each time, with warm water. Receives: Drug: Probiotics 6600 |
| CD control group | Placebo comparator | Patients diagnosed with Crohn's disease (CD) were given one tablet of placebo twice daily (morning and evening after meals) with warm water. Receives: Drug: Placebo |
| CD experimental group | Experimental | Patients diagnosed with Crohn's disease (CD) were given probiotics 6600 orally twice a day (morning and evening after meals), one tablet each time, with warm water. Receives: Drug: Probiotics 6600 |
| Colitis control group | Placebo comparator | Patients diagnosed with colitis (non-ulcerative colitis or Crohn's disease) were given one tablet of placebo twice daily (morning and evening after meals) with warm water. Receives: Drug: Placebo |
| Colitis experimental group | Experimental | For patients diagnosed with colitis (non-ulcerative colitis or Crohn's disease), take probiotic 6600 orally twice daily (morning and evening after meals), one tablet each time, with warm water. Receives: Drug: Probiotics 6600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate
To evaluate the efficacy of probiotic 6600 capsule in the adjuvant treatment of patients with colitis.
We assessed the rate of clinical remission (UC group: Mayo score ≤2 and no single subscore >1; CD group: CDAI score < 150; Colitis group: SCCAI score ≤2 and no single subscore >1).
Measured: To evaluate the effect of taking probiotic 6600 capsules in addition to usual care for 24 weeks on improving the rate of clinical remission compared with the control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047339
- Sponsor's protocol ID
- 6600
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis
- ClinicalTrials.gov ID
- NCT07047339
- Acronym / sponsor ID
- 6600
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jul 2025 (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.
This study was conducted in two phases. In Phase I, 40 UC participants, 40 CD participants, and 40 colitis participants were randomly assigned in a 1:1 ratio to the experimental group and the control group, respectively. The study included a screening period (1 week), a double-blind treatment period (24 weeks), an exit examination (1 day), and a safety follow-up period (4 weeks). After providing informed consent, participants who met the inclusion criteria and those who did not meet the exclusion criteria were randomly assigned, in a 1:1 ratio, to receive either the trial (probiotic 6600 capsules) or the control group (placebo). The clinical remission rate (SCCAI score ≤2 and no single subscore >1) after 24 weeks of treatment was calculated. Mayo score ≤2 and no single subscore >1; CDAI score ≤2 and no single subscore >1) were used as the primary efficacy index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| UC control group | Placebo comparator | Drug: PlaceboPatients diagnosed with ulcerative colitis (UC) were given one tablet of placebo twice daily (morning and evening after meals) with warm water. |
| UC experimental group | Experimental | Drug: Probiotics 6600Patients diagnosed with ulcerative colitis (UC) were given probiotics 6600 orally twice daily (morning and evening after meals), one tablet each time, with warm water. |
| CD control group | Placebo comparator | Drug: PlaceboPatients diagnosed with Crohn's disease (CD) were given one tablet of placebo twice daily (morning and evening after meals) with warm water. |
| CD experimental group | Experimental | Drug: Probiotics 6600Patients diagnosed with Crohn's disease (CD) were given probiotics 6600 orally twice a day (morning and evening after meals), one tablet each time, with warm water. |
| Colitis control group | Placebo comparator | Drug: PlaceboPatients diagnosed with colitis (non-ulcerative colitis or Crohn's disease) were given one tablet of placebo twice daily (morning and evening after meals) with warm water. |
| Colitis experimental group | Experimental | Drug: Probiotics 6600For patients diagnosed with colitis (non-ulcerative colitis or Crohn's disease), take probiotic 6600 orally twice daily (morning and evening after meals), one tablet each time, with warm water. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ulcerative colitis (UC) : met the clinical diagnostic criteria of UC "Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi 'an)", and modified Mayo score ≥4 points;
- Crohn's disease (CD) : met the clinical diagnostic criteria of CD "Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou)", and CDAI score ≥220;
- Colitis: clinical diagnosis of colitis and modified SCCAI score ≥3; 3.
- The age of signing the informed consent form was from 18 to 75 years old (including the cut-off value, male and female were not limited);
- Complete medical history;
Key exclusion criteria (10 listed)
- Taking prebiotics or probiotics in the past 2 weeks or allergic to intervention preparations;
- Short bowel syndrome, abdominal abscess, toxic megacolon, intestinal perforation, active fistula of digestive tract, severe intestinal stenosis with obstructive symptoms, suspected intestinal obstruction, total colectomy;
- Other autoimmune diseases, hematological diseases, tumors, acute infections, severe hepatic and renal insufficiency (ALT>2 times the upper limit of normal), severe diseases such as neutropenia, heart failure, organic heart disease, viral hepatitis B, liver cirrhosis, renal impairment (serum creatinine > 2mg/dL or 177mmol/L), AIDS And mental disorders;
- History of psychoactive substance abuse;
- A history of drug or other dependent substance abuse, or heavy alcohol consumption in the last 2 weeks (i.e. 28 standard units per week for men and 21 standard units per week for women (1 standard unit contains 14g of alcohol, such as 360mL of beer or 25mL of 40% spirits or 150mL of wine); Heavy drinkers during the trial;
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 |
|---|---|---|
| Probiotics 6600As the core commensal bacteria of human body, probiotic 6600 has a unique ability to synthesize adhesins and exopolysaccharides. The intestinal protective effect is mediated by the following mechanisms: (1) regulation of Treg/Th17 balance by producing short-chain fatty acids (SCFAs); (2) activation of TLR2/MyD88 pathway inhibits NF-κB inflammatory cascade; (3) Upregulation of zonula occludens-1 enhances intestinal barrier function. Notably, this strain specifically metabolized arabinoxylan to produce the anti-inflammatory metabolite indole lactate, which has important therapeutic value in the colitis microenvironment. Probiotic 6600 capsules are enteric capsules (containing probiotic 6600 10^11 CFU/ capsule), taken orally twice a day (after meals in the morning and evening), one capsule each time, and taken with warm water. The drug was stored at 2-8℃. | Drug | CD experimental group, Colitis experimental group, UC experimental group |
| PlaceboThe placebo capsules were also enteric-coated capsules, and were taken orally twice a day (morning and evening after meals), one capsule each time, with warm water. | Drug | CD control group, Colitis control group, UC control group |
Primary outcome
Clinical remission rate
Time frame: To evaluate the effect of taking probiotic 6600 capsules in addition to usual care for 24 weeks on improving the rate of clinical remission compared with the control group.
To evaluate the efficacy of probiotic 6600 capsule in the adjuvant treatment of patients with colitis. We assessed the rate of clinical remission (UC group: Mayo score ≤2 and no single subscore >1; CD group: CDAI score < 150; Colitis group: SCCAI score ≤2 and no single subscore >1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Probiotics 6600 in people with Colitis and IBD (Inflammatory Bowel Disease), run by Changhai Hospital 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Jul 2025. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate (time frame: To evaluate the effect of taking probiotic 6600 capsules in addition to usual care for 24 weeks on improving the rate of clinical remission compared with the control group.). 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 2 Jul 2025.