SafetyPhase 1/2NCT06974123
A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Teslanbaicin in Patients With Radiation Proctitis
A Phase 1/2 study testing A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Tesilanbaiju in Patients with Radiation Proctitis and Teslanbai oral therapy in people with Safety, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
Radiation Proctitis refers to rectal radiation injury caused by radiotherapy for pelvic malignancies. It is classified into Acute Radiation Proctitis (ARP) and Chronic Radiation Proctitis (CRP) based on onset time and disease progression, with a 3-month threshold distinguishing acute from chronic forms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety
- What is being tested?
- A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Tesilanbaiju in Patients with Radiation Proctitis and Teslanbai oral therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 31 Dec 2026
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation with signed informed consent form, good compliance, ability to cooperate with diagnosis, treatment, and follow-up; Age ≥18 years (inclusive), regardless of gender; Pathologically confirmed pelvic malignancies (via histology or cytology) requiring pelvic radiotherapy, clinically diagnosed with Grade 1-2 radiation proctitis (per CTCAE criteria); Karnofsky Performance Status (KPS) score ≥60; Expected survival period ≥6 months;
- Normal function of major organs, with laboratory values meeting the following criteria:
- Absolute neutrophil count (ANC) ≥1.5×10^9/L Platelets ≥75×10^9/L Hemoglobin ≥90g/L Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) >60 mL/min/1.73m² (Cockcroft-Gault formula) Total bilirubin <1.5×ULN AST/ALT <2.5×ULN (≤5×ULN for subjects with liver metastasis) Albumin (ALB) ≥30g/L INR or prothrombin time (PT) <1.5×ULN (if on anticoagulant therapy, PT must be within the intended therapeutic range).
Who cannot join
- Severe internal and external hemorrhoids; Allergy to any component of the investigational drug; Comorbid inflammatory bowel disease, irritable bowel syndrome, chronic gastrointestinal bleeding, or other diseases potentially associated with chronic diarrhea symptoms; Specific dietary habits prone to causing intestinal symptoms that cannot be modified; Personality or psychiatric disorders, individuals lacking civil capacity or with limited civil capacity; Medical history, conditions, treatments, or laboratory abnormalities that may interfere with trial results or hinder full participation; Other circumstances deemed unsuitable for study participation by the investigator.
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
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan
About this study
Radiation Proctitis refers to rectal radiation injury caused by radiotherapy for pelvic malignancies. It is classified into Acute Radiation Proctitis (ARP) and Chronic Radiation Proctitis (CRP) based on onset time and disease progression, with a 3-month threshold distinguishing acute from chronic forms. Over 75% of patients undergoing pelvic radiotherapy develop ARP, while 5%-20% progress to CRP. CRP patients experience persistent symptoms and severe late complications such as gastrointestinal bleeding, perforation, obstruction, and fistulas, which pose significant clinical challenges and severely impact quality of life.
Probiotics have long been used in treating radiation proctitis. Radiotherapy disrupts the intestinal microbiome, leading to dysbiosis. Probiotics help restore microbial balance, normalize intestinal pH, and alleviate diarrhea. Commonly used probiotics include Lactobacillus, Bifidobacterium, Enterococcus, and Lactic Acid Bacteria. Clinical studies indicate probiotics significantly reduce radiotherapy-associated diarrhea risk. However, evidence for their efficacy against other symptoms (e.g., hematochezia, anal pain, tenesmus) or severe complications remains limited. A meta-analysis of 904 patients confirmed probiotics outperform placebos in reducing diarrhea incidence and decreasing loperamide use or watery stool frequency during pelvic radiotherapy.
Read more
Lactobacillus rhamnosus, a key probiotic in the human gut, colonizes the gastrointestinal tract and improves inflammatory bowel disease (IBD) symptoms by balancing microbiota, enhancing mucosal barriers, modulating immunity, and suppressing inflammation. Studies show it protects mice from radiation-induced intestinal epithelial damage by reducing apoptosis, increasing crypt survival, and shielding epithelial stem cells.
Chronic intestinal inflammation elevates reactive oxygen species (ROS) levels. Excessive ROS oxidizes cellular structures, triggers inflammatory cytokine release, promotes collagen deposition and fibrosis, and accelerates intestinal barrier damage. Reducing ROS may thus aid IBD prevention and treatment. Selenium, a trace element essential for glutathione peroxidase, scavenges ROS. Lactobacillus rhamnosus cultured with nano-selenium enhances selenium bioavailability. Selenium-enriched Lactobacillus rhamnosus may synergistically modulate gut microbiota and lower ROS to suppress inflammation.
Lactobacillus rhamnosus, approved as a food probiotic, has been safely consumed by 2-5 million people daily since the mid-1990s. Teslanbai bacteria, a novel probiotic derived from Lactobacillus rhamnosus (strain CICC 6137 from China Center of Industrial Culture Collection), incorporates nano-selenium via fermentation and freeze-drying. Preclinical studies demonstrate that oral Teslanbai alleviates DSS-induced acute enteritis symptoms, prevents weight loss, improves intestinal ulcers, reduces vascular permeability, and restores barrier function in mice. Treated mice exhibited intact intestinal structures and formed stools. Safety assessments revealed no adverse effects on blood components or major organs, suggesting Teslanbai's potential efficacy against radiation proctitis.
- Conditions
- Safety
- Being tested
- A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Tesilanbaiju in Patients with Radiation Proctitis, Teslanbai oral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Tesilanbaiju in Patients with Radiation ProctitisDrug
Patients clinically diagnosed with radiation proctitis of CTCAE grade I-II will receive oral administration. Three dose groups of Teslanbai bacteria are tentatively planned, formulated as capsules with viable bacterial counts per capsule of ≥1107 CFU, 1108 CFU, and 1*109 CFU, respectively. A "3+3" dose-escalation design will be adopted. Each dose group will enroll 3 subjects. If 1 subject experiences a grade ≥3 adverse reaction, 3 additional patients will be added. If 2 subjects exhibit adverse reactions, enrollment into higher dose groups will be discontinued. The final dosage for subsequent use of Teslanbai bacteria will be determined based on efficacy and safety data.
Approximately 9 subjects are planned for enrollment. After determining the optimal dosage, investigators and sponsors will decide whether to proceed to Phase II based on the study results and external data.
Teslanbai oral therapyDrug
A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Tesilanbaiju in Patients with Radiation Proctitis
| Study group | Role | What they receive |
|---|---|---|
| arm one | Experimental | Not described Receives: Drug: A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Tesilanbaiju in Patients with Radiation Proctitis; Drug: Teslanbai oral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of oral administration of Teslancure in patients with radiation proctitis
Efficacy and Safety Follow up
- Efficacy Evaluation Plan Frequency : Initial assessment at Day 30 (±3 days) after the first dose, then every 4 weeks (±3 days) thereafter. Termination Criteria : Subject death, withdrawal of informed consent, or study completion. Assessment Items : Physical examination Vital signs (blood pressure, heart rate, temperature, etc.) KPS Score (Karnofsky Performance Status) Patient reported outcomes (EORTC QLQ C30 questionnaire) Concomitant medications/treatments Adverse events (AEs) Laboratory tests (blood tests, biochemistry, etc., as per protocol) Vienna Rectoscopy Score (if applicable)
- Safety Follow up Plan (1) Telephone Follow up Time Points : Day 7 (±3 days) and Day 15 (±3 days) after the first dose.
Content :
Recording of adverse events (AEs) Assessment of clinical symptom relief
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start15 Oct 2024
- Primary completion31 Dec 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 SafetyStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974123
- Sponsor's protocol ID
- NO.[2024] 37
- Status last verified
- Oct 2024
- First submitted
- 7 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Teslanbaicin in Patients With Radiation Proctitis
- ClinicalTrials.gov ID
- NCT06974123
- Acronym / sponsor ID
- NO.[2024] 37
- Conditions
- Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 May 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.
Radiation Proctitis refers to rectal radiation injury caused by radiotherapy for pelvic malignancies. It is classified into Acute Radiation Proctitis (ARP) and Chronic Radiation Proctitis (CRP) based on onset time and disease progression, with a 3-month threshold distinguishing acute from chronic forms. Over 75% of patients undergoing pelvic radiotherapy develop ARP, while 5%-20% progress to CRP. CRP patients experience persistent symptoms and severe late complications such as gastrointestinal bleeding, perforation, obstruction, and fistulas, which pose significant clinical challenges and severely impact quality of life.
Probiotics have long been used in treating radiation proctitis. Radiotherapy disrupts the intestinal microbiome, leading to dysbiosis. Probiotics help restore microbial balance, normalize intestinal pH, and alleviate diarrhea. Commonly used probiotics include Lactobacillus, Bifidobacterium, Enterococcus, and Lactic Acid Bacteria. Clinical studies indicate probiotics significantly reduce radiotherapy-associated diarrhea risk. However, evidence for their efficacy against other symptoms (e.g., hematochezia, anal pain, tenesmus) or severe complications remains limited. A meta-analysis of 904 patients confirmed probiotics outperform placebos in reducing diarrhea incidence and decreasing loperamide use or watery stool frequency during pelvic radiotherapy.
Lactobacillus rhamnosus, a key probiotic in the human gut, colonizes the gastrointestinal tract and improves inflammatory bowel disease (IBD) symptoms by balancing microbiota, enhancing mucosal barriers, modulating immunity, and suppressing inflammation. Studies show it protects mice from radiation-induced intestinal epithelial damage by reducing apoptosis, increasing crypt survival, and shielding epithelial stem cells.
Chronic intestinal inflammation elevates reactive oxygen species (ROS) levels. Excessive ROS oxidizes cellular structures, triggers inflammatory cytokine release, promotes collagen deposition and fibrosis, and accelerates intestinal barrier damage. Reducing ROS may thus aid IBD prevention and treatment. Selenium, a trace element essential for glutathione peroxidase, scavenges ROS. Lactobacillus rhamnosus cultured with nano-selenium enhances selenium bioavailability. Selenium-enriched Lactobacillus rhamnosus may synergistically modulate gut microbiota and lower ROS to suppress inflammation.
Lactobacillus rhamnosus, approved as a food probiotic, has been safely consumed by 2-5 million people daily since the mid-1990s. Teslanbai bacteria, a novel probiotic derived from Lactobacillus rhamnosus (strain CICC 6137 from China Center of Industrial Culture Collection), incorporates nano-selenium via fermentation and freeze-drying. Preclinical studies demonstrate that oral Teslanbai alleviates DSS-induced acute enteritis symptoms, prevents weight loss, improves intestinal ulcers, reduces vascular permeability, and restores barrier function in mice. Treated mice exhibited intact intestinal structures and formed stools. Safety assessments revealed no adverse effects on blood components or major organs, suggesting Teslanbai's potential efficacy against radiation proctitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm one | Experimental | Drug: A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Tesilanbaiju in Patients with Radiation Proctitis, Drug: Teslanbai oral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntary participation with signed informed consent form, good compliance, ability to cooperate with diagnosis, treatment, and follow-up; Age ≥18 years (inclusive), regardless of gender; Pathologically confirmed pelvic malignancies (via histology or cytology) requiring pelvic radiotherapy, clinically diagnosed with Grade 1-2 radiation proctitis (per CTCAE criteria); Karnofsky Performance Status (KPS) score ≥60; Expected survival period ≥6 months;
- Absolute neutrophil count (ANC) ≥1.5×10^9/L Platelets ≥75×10^9/L Hemoglobin ≥90g/L Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) >60 mL/min/1.73m² (Cockcroft-Gault formula) Total bilirubin <1.5×ULN AST/ALT <2.5×ULN (≤5×ULN for subjects with liver metastasis) Albumin (ALB) ≥30g/L INR or prothrombin time (PT) <1.5×ULN (if on anticoagulant therapy, PT must be within the intended therapeutic range).
Key exclusion criteria (1 listed)
- Severe internal and external hemorrhoids; Allergy to any component of the investigational drug; Comorbid inflammatory bowel disease, irritable bowel syndrome, chronic gastrointestinal bleeding, or other diseases potentially associated with chronic diarrhea symptoms; Specific dietary habits prone to causing intestinal symptoms that cannot be modified; Personality or psychiatric disorders, individuals lacking civil capacity or with limited civil capacity; Medical history, conditions, treatments, or laboratory abnormalities that may interfere with trial results or hinder full participation; Other circumstances deemed unsuitable for study participation by the investigator.
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 |
|---|---|---|
| A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Tesilanbaiju in Patients with Radiation ProctitisPatients clinically diagnosed with radiation proctitis of CTCAE grade I-II will receive oral administration. Three dose groups of Teslanbai bacteria are tentatively planned, formulated as capsules with viable bacterial counts per capsule of ≥1107 CFU, 1108 CFU, and 1*109 CFU, respectively. A "3+3" dose-escalation design will be adopted. Each dose group will enroll 3 subjects. If 1 subject experiences a grade ≥3 adverse reaction, 3 additional patients will be added. If 2 subjects exhibit adverse reactions, enrollment into higher dose groups will be discontinued. The final dosage for subsequent use of Teslanbai bacteria will be determined based on efficacy and safety data. Approximately 9 subjects are planned for enrollment. After determining the optimal dosage, investigators and sponsors will decide whether to proceed to Phase II based on the study results and external data. | Drug | arm one |
| Teslanbai oral therapyA Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Tesilanbaiju in Patients with Radiation Proctitis | Drug | arm one |
Primary outcome
Evaluate the safety of oral administration of Teslancure in patients with radiation proctitis
Time frame: From enrollment to the end of treatment at 8 weeks
Efficacy and Safety Follow up 1. Efficacy Evaluation Plan Frequency : Initial assessment at Day 30 (±3 days) after the first dose, then every 4 weeks (±3 days) thereafter. Termination Criteria : Subject death, withdrawal of informed consent, or study completion. Assessment Items : Physical examination Vital signs (blood pressure, heart rate, temperature, etc.) KPS Score (Karnofsky Performance Status) Patient reported outcomes (EORTC QLQ C30 questionnaire) Concomitant medications/treatments Adverse events (AEs) Laboratory tests (blood tests, biochemistry, etc., as per protocol) Vienna Rectoscopy Score (if applicable) 2. Safety Follow up Plan (1) Telephone Follow up Time Points : Day 7 (±3 days) and Day 15 (±3 days) after the first dose. Content : Recording of adverse events (AEs) Assessment of clinical symptom relief
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 15 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Tesilanbaiju in Patients with Radiation Proctitis and Teslanbai oral therapy in people with Safety, run by The First Affiliated Hospital of Xinxiang Medical College 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 1 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: enrolling by invitation, as of the sponsor's last update on 15 May 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of oral administration of Teslancure in patients with radiation proctitis (time frame: From enrollment to the end of treatment at 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 15 May 2025; AzTrials last refreshed its copy on 3 Nov 2026.