Radiation ProctitisPhase 2/3NCT05406882
The Effects of Probiotics Combined With Glutamine in the Prevention and Treatment of Radiation Proctitis
A Phase 2/3 study testing Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules in people with Radiation Proctitis and Probiotics, run by West China Hospital at 2 sites in China.
Trial summary
Radiation proctitis is a common complication after radiation therapy for pelvic tumors. The investigators found that live bifidobacterium and lactobacillus tablets combined with compound glutamine enteric-coated capsules can significantly relieve the symptoms of radiation proctitis through preliminary clinical… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiation Proctitis, Probiotics, Glutamine
- What is being tested?
- Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 2 sitesChina
- Study dates
- 15 Apr 2022to 30 Sep 2024
- Phase
- Phase 2/3
- 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
- locally advanced rectal adenocarcinoma diagnosed by histopathology; clinical stage T3/4 or N+(AJCC,8th), no metastasis; and planned to receive preoperative neoadjuvant concurrent chemoradiotherapy.
- without other malignant tumors;
- Those without serious heart, liver, kidney and other diseases;
- ECOG score: 0-1.
Who cannot join
- Complicated with ulcerative colitis or Crohn's disease;
- Complicated with severe organ insufficiency, severe diabetes, and heart disease;
- Pregnant and lactating women;
- Abnormal bowel movements with systemic and metabolic diseases;
- The patient has a history of using systemic antibiotics and intestinal active bacteria in the past 1 month.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Xin Wang, PhD/MD, +86 28 85423609, wangxin213@sina.com
- Recruiting
Xin Wang
Chengdu, Sichuan, 610041
xin wang, PhD/MD, +86 28 85423609, wangxin213@sina.com
About this study
Official title: The Effects of Bifidobacterium and Lactobacillus Tablets Combined With Compound Glutamine in the Prevention and Treatment of Radiation Proctitis.
Radiation proctitis is a common complication after radiation therapy for pelvic tumors. The investigators found that live bifidobacterium and lactobacillus tablets combined with compound glutamine enteric-coated capsules can significantly relieve the symptoms of radiation proctitis through preliminary clinical practice, but the mechanism is unknown. Through a prospective randomized controlled study, this study intends to investigate the incidence of grade 2 or higher acute radiation proctitis in patients of locally advanced rectal cancer after radiotherapy with the combined therapy. And through various scales, next-generation sequencing methods and other methods to evaluate the clinical symptoms, colonoscopy, imaging, and changes in the species and abundance of intestinal flora before and after treatment. To further explore the related pathways and mechanisms affecting radiation proctitis.
- Conditions
- Radiation Proctitis, Probiotics, Glutamine, Gut Microbiota, Bifidobacterium
- Being tested
- Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsulesDrug
Also called Probiotics、Glutamine
Live Combined Bifidobacterium and Lactobacillus Tablets：probiotics. Compound Glutamine Entersoluble capsules：combined traditional Chinese medicine and glutamine
| Study group | Role | What they receive |
|---|---|---|
| combination therapy group | Experimental | From the first day of chemoradiotherapy, live combined Bifidobacterium and Lactobacillus tablets(2000mg each time, 3 times/day) combined with compound glutamine enteric-coated capsules (3 capsules each time, 3 times/day) until 1 month after the end of chemoradiotherapy. Receives: Drug: Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules |
| control group | No intervention | After the start of chemoradiotherapy, the control group don't take the experimental drug orally . When patients have radiation proctitis of grade ≥2, they would be crossed over to the combined treatment group：live combined Bifidobacterium and Lactobacillus tablets(2000mg each time, 3 times/day) combined with compound glutamine enteric-coated capsules (3 capsules each time, 3 times/day) until 1 month after the end of chemoradiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of radiation proctitis
Incidence of grade ≥2 radiation proctitis in combination therapy group
Measured: two months
Secondary outcomes (1)
remission rate of radiation proctitis
remission rate of radiation proctitis after combined treatment in control group developed radiation proctitis of grade ≥2
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start15 Apr 2022
- Primary completion15 Apr 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ProctitisStudies of the same condition, open and under way.
- More trials run by West China 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xin, West China Hospital
- Investigators
- xin wang, Principal investigator, China, SiChuan West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406882
- Sponsor's protocol ID
- HX-H2112345
- Status last verified
- Jul 2022
- First submitted
- 6 May 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bifidobacterium and Lactobacillus Tablets Combined With Compound Glutamine in the Prevention and Treatment of Radiation Proctitis.
- ClinicalTrials.gov ID
- NCT05406882
- Acronym / sponsor ID
- HX-H2112345
- Conditions
- Radiation Proctitis, Probiotics, Glutamine, Gut Microbiota, Bifidobacterium
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 7 Jun 2022 (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 is a common complication after radiation therapy for pelvic tumors. The investigators found that live bifidobacterium and lactobacillus tablets combined with compound glutamine enteric-coated capsules can significantly relieve the symptoms of radiation proctitis through preliminary clinical practice, but the mechanism is unknown. Through a prospective randomized controlled study, this study intends to investigate the incidence of grade 2 or higher acute radiation proctitis in patients of locally advanced rectal cancer after radiotherapy with the combined therapy. And through various scales, next-generation sequencing methods and other methods to evaluate the clinical symptoms, colonoscopy, imaging, and changes in the species and abundance of intestinal flora before and after treatment. To further explore the related pathways and mechanisms affecting radiation proctitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination therapy group | Experimental | Drug: Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsulesFrom the first day of chemoradiotherapy, live combined Bifidobacterium and Lactobacillus tablets(2000mg each time, 3 times/day) combined with compound glutamine enteric-coated capsules (3 capsules each time, 3 times/day) until 1 month after the end of chemoradiotherapy. |
| control group | No intervention | –After the start of chemoradiotherapy, the control group don't take the experimental drug orally . When patients have radiation proctitis of grade ≥2, they would be crossed over to the combined treatment group：live combined Bifidobacterium and Lactobacillus tablets(2000mg each time, 3 times/day) combined with compound glutamine enteric-coated capsules (3 capsules each time, 3 times/day) until 1 month after the end of chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- locally advanced rectal adenocarcinoma diagnosed by histopathology; clinical stage T3/4 or N+(AJCC,8th), no metastasis; and planned to receive preoperative neoadjuvant concurrent chemoradiotherapy.
- without other malignant tumors;
- Those without serious heart, liver, kidney and other diseases;
- ECOG score: 0-1.
Key exclusion criteria (5 listed)
- Complicated with ulcerative colitis or Crohn's disease;
- Complicated with severe organ insufficiency, severe diabetes, and heart disease;
- Pregnant and lactating women;
- Abnormal bowel movements with systemic and metabolic diseases;
- The patient has a history of using systemic antibiotics and intestinal active bacteria in the past 1 month.
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 |
|---|---|---|
| Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsulesAlso: Probiotics、GlutamineLive Combined Bifidobacterium and Lactobacillus Tablets：probiotics. Compound Glutamine Entersoluble capsules：combined traditional Chinese medicine and glutamine | Drug | combination therapy group |
Primary outcome
Incidence of radiation proctitis
Time frame: two months
Incidence of grade ≥2 radiation proctitis in combination therapy group
1 secondary outcome
remission rate of radiation proctitis
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
Related trials for Radiation Proctitis
RecruitingPhase 2
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Radiation Induced Proctitis
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A Study of Chlorophyllin or Placebo With Standard Treatment for Late Radiation Induced Luminal Gastrointestinal Tract Bleeding
Radiation Proctitis, Gastrointestinal Hemorrhage
RecruitingObservational study
Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)
Pelvic Toxicity, Radiation Toxicity
RecruitingObservational study
Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy
Radiotherapy, Radiation Proctitis
RecruitingPhase 2
Dietary Supplements to Treat Radiation-Induced Rectal Injury
Radiotherapy, Radiation Proctitis
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.
xin wang principal investigator
China, SiChuan West China Hospital
2 sites 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 Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules in people with Radiation Proctitis and Probiotics, run by West China Hospital at 2 sites 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 4 inclusion and 5 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 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xin wang, PhD/MD (+86 28 85423609, wangxin213@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of radiation proctitis (time frame: two months). 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 Jul 2022.