Colon AdenocarcinomaPROBIOCOLNCT07733817
Impact of Probiotics on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer.
A study testing PROBIOTIC SUPPLEMENTATION BY OXXYSLAB® in people with Colon Adenocarcinoma and Neuropathic Pain, run by Centre Francois Baclesse at 7 sites in France.
Trial summary
The pbjective of this study is to assess the impact of a multi-strain bacteria probiotic OXXYSLAB® on the reduction of oxaliplatin-induced peripheral neuropathy in patients with stage III colon cancer receiving FOLFOX or XELOX regimen in adjuvant treatment, assessed using the oxaliplatin-specific scale of Levi. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Adenocarcinoma, Neuropathic Pain
- What is being tested?
- PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Oct 2026to 1 Apr 2036
- Phase
- Interventional
- 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
- Patient ≥ 18 years
- Patient with histologically confirmed stage III adenocarcinoma colon cancer with curative resection
- Patient with an indication to start adjuvant oxaliplatin-based chemotherapy (FOLFOX 4 or XELOX regimen)
- ECOG performance status score of 0 or 1
- Patient must consent to allow the collection of fecal and blood samples during study for further ancillary studies
- Screening laboratory values must meet the following criteria:
Show all 33Show fewer
- Neutrophils ≥ 1500/ mm³; Platelets ≥ 100 000/ mm³; Hemoglobin ≥ 9.0 g/dL
- Bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN
- Serum creatinine ≤ 1.5 x ULN or measured or calculated creatinine ≥ 50 ml/min clearance (CrCl) (using the Cockcroft-Gault formula)
- Patient with French language comprehension
- Female subject of childbearing potential must have a negative urine or serum pregnancy test within 7 days before study probiotics supplementation start
- Patient in reproductive age must be willing to use adequate contraception during study probiotics supplementation
- Patient affiliated to an appropriate social security system
- Patient has signed informed consent obtained before to any study specific procedures
- Enclusion Criteria:
- Patient with any distant metastasis
- Patient with current peripheral neuropathy of any grade or ongoing treatment prescribed to prevent or treat peripheral neuropathy
- Patient with hypersensitivity to any ingredients in the composition of the multi-strain formulation and/or maltose
- Patient with history of acute pancreatitis
- Patient seriously immunosuppressed
- Patient with history of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
- Patient using of probiotics or antibiotic treatments within one month before inclusion
- Patient with chronic inflammatory gastro-intestinal disease
- Patient with uracilemia ≥ 16 ng/ml
- Patient with QT/QTc > 450 msec for men and > 470 msec for women
- Patient with active infection requiring systemic therapy
- Patient with personality disorder or any other known progressive psychiatric pathology
- Patient with neurological previous history with ongoing symptoms (sequelae of head trauma, stroke, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.)
- Patient with dependence on alcohol and / or drugs
- Pregnant or lactating woman
- Simultaneous participation in another clinical study that may compromise the conduct of this study.
- Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- Patient deprived of liberty or placed under the authority of a tutor
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
Ch Aunay-Bayeux
Bayeux
Anne PEYTIER, a.peytier@ch-ab.fr
Centre François Baclesse
Caen, Centre François Baclesse, 14076
Mélanie DOS SANTOS, MD, 0231455050, m.dossantos@baclesse.unicancer.fr
CHU
Caen
Karine BOUHIER-LEPORRIER, bouhierleporrier-k@chu-caen.fr
Centre Oscar Lambret
Lille
Flore PIGNON, f-pignon@o-lambret.fr
CHU
Lille
Anne PLOQUIN, anne.ploquin@chu-lille.fr
CHU
Rouen
Adrien GRANCHER, Adrien.Grancher@chu-rouen.fr
CH
Saint-Lô
Jérôme MEUNIER, jerome.meunier@ch-stlo.fr
About this study
Official title: Impact of Probiotic Supplementation on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer: a Phase III Randomized Study
The pbjective of this study is to assess the impact of a multi-strain bacteria probiotic OXXYSLAB® on the reduction of oxaliplatin-induced peripheral neuropathy in patients with stage III colon cancer receiving FOLFOX or XELOX regimen in adjuvant treatment, assessed using the oxaliplatin-specific scale of Levi.
Read the detailed description
Patients are randomized (1:1 ratio), between:
- Experimental group: Multi-strain PROBIOTIC treatment (OXXYSLAB®) 1.5 g sachet containing maltose and the OXXYSLAB® multi-strain probiotic formulation (eight different live bacterial strains, 200 billion bacteria).
- Control group: PLACEBO treatment 1.5 g sachet strictly identical to OXXYSLAB®, containing maltose only.
- Conditions
- Colon Adenocarcinoma, Neuropathic Pain
- Being tested
- PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®, PLACEBO supplementation
- Keywords
- FOLFOX, PROBIOTICS, XELOX
- Medical subject headings
- Colonic Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®Dietary supplement
PROBIOTIC treatment (OXXYSLAB®) starts 1 week before first administration of chemotherapy (XELOX or FOLFOX) and be continued until 1 week after end of the last cycle of chemotherapy.
PROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose.
PLACEBO supplementationDietary supplement
PLACEBO supplementation starts 1 week before first administration of chemotherapy (XELOX or FOLFOX) and be continued until 1 week after end of the last cycle of chemotherapy.
PROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Multi-strain PROBIOTIC treatment Receives: Dietary Supplement: PROBIOTIC SUPPLEMENTATION BY OXXYSLAB® |
| Control group | Placebo comparator | PLACEBO treatment Receives: Dietary Supplement: PLACEBO supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who experience a grade ≥2 peripheral neuropathy
Oxaliplatin-specific scale of Levi [min grade 0 (better)- max Grade 4 (worse)] after 6 cycles for FOLFOX or 4 cycles for XELOX
Measured: Around week 12 (+/- 7 days) after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenocarcinomaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733817
- Sponsor's protocol ID
- 2026-A00155-46
- Other IDs
- 2026-A00155-46
- Acronym
- PROBIOCOL
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Probiotic Supplementation on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer: a Phase III Randomized Study
- ClinicalTrials.gov ID
- NCT07733817
- Acronym / sponsor ID
- PROBIOCOL / 2026-A00155-46
- Conditions
- Colon Adenocarcinoma, Neuropathic Pain
- Keywords
- FOLFOX, PROBIOTICS, XELOX
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2036 (estimated)
- First posted
- 29 Jul 2026 (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 pbjective of this study is to assess the impact of a multi-strain bacteria probiotic OXXYSLAB® on the reduction of oxaliplatin-induced peripheral neuropathy in patients with stage III colon cancer receiving FOLFOX or XELOX regimen in adjuvant treatment, assessed using the oxaliplatin-specific scale of Levi.
Detailed description
Patients are randomized (1:1 ratio), between:
- Experimental group: Multi-strain PROBIOTIC treatment (OXXYSLAB®) 1.5 g sachet containing maltose and the OXXYSLAB® multi-strain probiotic formulation (eight different live bacterial strains, 200 billion bacteria).
- Control group: PLACEBO treatment 1.5 g sachet strictly identical to OXXYSLAB®, containing maltose only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®Multi-strain PROBIOTIC treatment |
| Control group | Placebo comparator | Dietary Supplement: PLACEBO supplementationPLACEBO treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Patient ≥ 18 years
- Patient with histologically confirmed stage III adenocarcinoma colon cancer with curative resection
- Patient with an indication to start adjuvant oxaliplatin-based chemotherapy (FOLFOX 4 or XELOX regimen)
- ECOG performance status score of 0 or 1
- Patient must consent to allow the collection of fecal and blood samples during study for further ancillary studies
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®PROBIOTIC treatment (OXXYSLAB®) starts 1 week before first administration of chemotherapy (XELOX or FOLFOX) and be continued until 1 week after end of the last cycle of chemotherapy. PROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose. | Dietary supplement | Experimental group |
| PLACEBO supplementationPLACEBO supplementation starts 1 week before first administration of chemotherapy (XELOX or FOLFOX) and be continued until 1 week after end of the last cycle of chemotherapy. PROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose. | Dietary supplement | Control group |
Primary outcome
Proportion of patients who experience a grade ≥2 peripheral neuropathy
Time frame: Around week 12 (+/- 7 days) after initiation of treatment
Oxaliplatin-specific scale of Levi [min grade 0 (better)- max Grade 4 (worse)] after 6 cycles for FOLFOX or 4 cycles for XELOX
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 30 Jul 2026.
- 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROBIOTIC SUPPLEMENTATION BY OXXYSLAB® in people with Colon Adenocarcinoma and Neuropathic Pain, run by Centre Francois Baclesse at 7 sites in France.
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 33 inclusion and 0 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: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
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?
Contact Mélanie DOS SANTOS, MD (+33231455050, m.dossantos@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who experience a grade ≥2 peripheral neuropathy (time frame: Around week 12 (+/- 7 days) after initiation of treatment). 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 30 Jul 2026.