Short Bowel SyndromePhase 1GRAALNCT05302531
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome
A Phase 1 study testing Amoxicillin, Levofloxacin and Ofloxacin in people with Short Bowel Syndrome and Infection, Bacterial, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose of this study is to assess the drug absorption of oral antibiotics in patients with short bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome, Infection, Bacterial
- What is being tested?
- Amoxicillin, Levofloxacin and Ofloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2022to Feb 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Short bowel syndrome
- Treated for a documented infection with antibiogram by amoxicillin (+/- clavulanic acid)or ofloxacin or levofloxacin or sulfamethoxazole/trimethoprim
- Hospitalized in the Nutritional Assistant Unit or the Infectiology Unit of the Regional University Hospital of Nancy
- Affiliated to a social security system
- Having received an physical examination before entering study
- Having received full information regarding the study organization and having signed the informed consent
Who cannot join
- Patient at risk of worsening their oral absorption abilities during study
- Patient requiring dialysis
- Women of childbearing age without efficient birth control
- Allergy to any of the drugs tested
- Person concerned by Articles L. 1121-5, L. 1121-7 et L1121-8 of the Code of public health
- Person deprived of liberty or person undergoing psychiatric care pursuant to articles L. 3212-1 et L. 3213-1
Trial locations and contacts
1 site in 1 country.
Elise Pape contact
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Vandœuvre-lès-Nancy, Lorraine, 54500
Niasha MICHOT, MD, +33383155108, n.michot@chru-nancy.fr
Julie LECOMTE, +33383155278, ju.lecomte@chru-nancy.fr
About this study
Official title: Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome : a Monocentric Pilot Study
The purpose of this study is to assess the drug absorption of oral antibiotics in patients with short bowel syndrome.
Read the detailed description
When required, due to an infection, patients with short bowel syndrome will be treated with an intravenous antibiotic. The pharmacokinetic profile of that intravenous antibiotic will be determined. Once the full treatment with the intravenous antibiotic is over, the patient will be orally administered the same antibiotic, with determination of the oral pharmacokinetic profile, and both profiles will be compared, assessing the bioavailability of the oral antibiotic.
- Conditions
- Short Bowel Syndrome, Infection, Bacterial
- Being tested
- Amoxicillin, Levofloxacin, Ofloxacin, Sulfamethoxazole trimethoprim
- Medical subject headings
- Short Bowel Syndrome, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
LevofloxacinDrug
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
OfloxacinDrug
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Sulfamethoxazole trimethoprimDrug
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Experimental | Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic. Receives: Drug: Amoxicillin |
| Ofloxacin | Experimental | Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic. Receives: Drug: Ofloxacin |
| Levofloxacin | Experimental | Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic. Receives: Drug: Levofloxacin |
| Sulfamethoxazole trimethoprim | Experimental | Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic. Receives: Drug: Sulfamethoxazole trimethoprim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Measured: Time -0.5 hours
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Measured: Time +0.5 hours
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Measured: Time +1 hour
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Measured: Time +1.5 hour
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Measured: Time +2 hours
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Measured: Time +4 hours
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Measured: Time +6 hours
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Measured: Time +8 hours
Secondary outcomes (4)
Describe antibiotic absorption after oral administration in these patients
Peak plasma concentration (Cmax) after oral intake
Measured: Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
Describe antibiotic absorption after oral administration in these patients
Peak plasma concentration time after oral intake (Tmax)
Measured: Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
Describe antibiotic absorption after oral administration in these patients
Area under the plasma concentration versus time curve (AUC)
Measured: Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
Assess link between length of remaining bowel and antibiotic absorption
Length of remaining bowel (cm)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start9 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Société Francophone Nutrition Clinique et Métabolisme, FIlière des Maladies rares Abdomino-THOraciques, Fresenius Kabi
- Responsible party
- Principal investigator, MICHOT Niasha, Central Hospital, Nancy, France
- Investigators
- Niasha MICHOT, MD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302531
- Sponsor's protocol ID
- 2021-001468-13
- Acronym
- GRAAL
- Status last verified
- Aug 2024
- First submitted
- 2 Mar 2022
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on first results, this pilot study might be extended in a new multicenter study
Publications
Scala-Bertola J, Rabiskova M, Lecompte T, Bonneaux F, Maincent P. Granules in the improvement of oral heparin bioavailability. Int J Pharm. 2009 Jun 5;374(1-2):12-6. doi: 10.1016/j.ijpharm.2009.02.020. Epub 2009 Mar 9.
PubMed 19446753American Gastroenterological Association. American Gastroenterological Association medical position statement: short bowel syndrome and intestinal transplantation. Gastroenterology. 2003 Apr;124(4):1105-10. doi: 10.1053/gast.2003.50139. No abstract available.
PubMed 12671903Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, Joly F, Kelly D, Lal S, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM; Home Artificial Nutrition & Chronic Intestinal Failure Special Interest Group of ESPEN. ESPEN guidelines on chronic intestinal failure in adults. Clin Nutr. 2016 Apr;35(2):247-307. doi: 10.1016/j.clnu.2016.01.020. Epub 2016 Feb 8.
PubMed 26944585Gupta A, Mehta Y, Juneja R, Trehan N. The effect of cannula material on the incidence of peripheral venous thrombophlebitis. Anaesthesia. 2007 Nov;62(11):1139-42. doi: 10.1111/j.1365-2044.2007.05180.x.
PubMed 17924895Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006 Sep;81(9):1159-71. doi: 10.4065/81.9.1159.
PubMed 16970212Ward N. The impact of intestinal failure on oral drug absorption: a review. J Gastrointest Surg. 2010 Jun;14(6):1045-51. doi: 10.1007/s11605-009-1151-9. Epub 2010 Jan 22.
PubMed 20094812Vance-Bryan K, Guay DR, Rotschafer JC. Clinical pharmacokinetics of ciprofloxacin. Clin Pharmacokinet. 1990 Dec;19(6):434-61. doi: 10.2165/00003088-199019060-00003.
PubMed 2292168Lamp KC, Bailey EM, Rybak MJ. Ofloxacin clinical pharmacokinetics. Clin Pharmacokinet. 1992 Jan;22(1):32-46. doi: 10.2165/00003088-199222010-00004.
PubMed 1559306Barr WH, Zola EM, Candler EL, Hwang SM, Tendolkar AV, Shamburek R, Parker B, Hilty MD. Differential absorption of amoxicillin from the human small and large intestine. Clin Pharmacol Ther. 1994 Sep;56(3):279-85. doi: 10.1038/clpt.1994.138.
PubMed 7924123Severijnen R, Bayat N, Bakker H, Tolboom J, Bongaerts G. Enteral drug absorption in patients with short small bowel : a review. Clin Pharmacokinet. 2004;43(14):951-62. doi: 10.2165/00003088-200443140-00001.
PubMed 15530127Cheung YW, Barco S, Mathot RAA, van den Dool EJ, Stroobants AK, Serlie MJ, Middeldorp S, Coppens M. Pharmacokinetics of dabigatran etexilate and rivaroxaban in patients with short bowel syndrome requiring parenteral nutrition: The PDER PAN study. Thromb Res. 2017 Dec;160:76-82. doi: 10.1016/j.thromres.2017.10.025. Epub 2017 Nov 4.
PubMed 29127863Faye E, Drouet L, De Raucourt E, Green A, Bal-Dit-Sollier C, Boudaoud L, Corcos O, Bergmann JF, Joly F, Lloret-Linares C. Absorption and efficacy of acetylsalicylic acid in patients with short bowel syndrome. Ann Pharmacother. 2014 Jun;48(6):705-10. doi: 10.1177/1060028014526700. Epub 2014 Mar 25.
PubMed 24667978Thielke J, Martin J, Weber FL, Schroeder TJ, Goretsky S, Hanto DW. Pharmacokinetics of tacrolimus and cyclosporine in short-bowel syndrome. Liver Transpl Surg. 1998 Sep;4(5):432-4. doi: 10.1002/lt.500040502. No abstract available.
PubMed 9724482Ueno T, Tanaka A, Hamanaka Y, Suzuki T. Serum drug concentrations after oral administration of paracetamol to patients with surgical resection of the gastrointestinal tract. Br J Clin Pharmacol. 1995 Mar;39(3):330-2. doi: 10.1111/j.1365-2125.1995.tb04457.x.
PubMed 7619677Menardi G, Guggenbichler JP. Bioavailability of oral antibiotics in children with short-bowel syndrome. J Pediatr Surg. 1984 Feb;19(1):84-6. doi: 10.1016/s0022-3468(84)80023-8.
PubMed 6699766
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome : a Monocentric Pilot Study
- ClinicalTrials.gov ID
- NCT05302531
- Acronym / sponsor ID
- GRAAL / 2021-001468-13
- Conditions
- Short Bowel Syndrome, Infection, Bacterial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Société Francophone Nutrition Clinique et Métabolisme, FIlière des Maladies rares Abdomino-THOraciques, Fresenius Kabi
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 31 Mar 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.
The purpose of this study is to assess the drug absorption of oral antibiotics in patients with short bowel syndrome.
Detailed description
When required, due to an infection, patients with short bowel syndrome will be treated with an intravenous antibiotic. The pharmacokinetic profile of that intravenous antibiotic will be determined. Once the full treatment with the intravenous antibiotic is over, the patient will be orally administered the same antibiotic, with determination of the oral pharmacokinetic profile, and both profiles will be compared, assessing the bioavailability of the oral antibiotic.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin | Experimental | Drug: AmoxicillinEach patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic. |
| Ofloxacin | Experimental | Drug: OfloxacinEach patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic. |
| Levofloxacin | Experimental | Drug: LevofloxacinEach patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic. |
| Sulfamethoxazole trimethoprim | Experimental | Drug: Sulfamethoxazole trimethoprimEach patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Short bowel syndrome
- Treated for a documented infection with antibiogram by amoxicillin (+/- clavulanic acid)or ofloxacin or levofloxacin or sulfamethoxazole/trimethoprim
- Hospitalized in the Nutritional Assistant Unit or the Infectiology Unit of the Regional University Hospital of Nancy
- Affiliated to a social security system
- Having received an physical examination before entering study
Key exclusion criteria (6 listed)
- Patient at risk of worsening their oral absorption abilities during study
- Patient requiring dialysis
- Women of childbearing age without efficient birth control
- Allergy to any of the drugs tested
- Person concerned by Articles L. 1121-5, L. 1121-7 et L1121-8 of the Code of public health
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 |
|---|---|---|
| AmoxicillinEach patient will receive the proper antibiotic to treat the infection, first intravenously, then orally | Drug | Amoxicillin |
| LevofloxacinEach patient will receive the proper antibiotic to treat the infection, first intravenously, then orally | Drug | Levofloxacin |
| OfloxacinEach patient will receive the proper antibiotic to treat the infection, first intravenously, then orally | Drug | Ofloxacin |
| Sulfamethoxazole trimethoprimEach patient will receive the proper antibiotic to treat the infection, first intravenously, then orally | Drug | Sulfamethoxazole trimethoprim |
Primary outcome
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Time frame: Time -0.5 hours
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Time frame: Time +0.5 hours
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Time frame: Time +1 hour
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Time frame: Time +1.5 hour
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Time frame: Time +2 hours
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Time frame: Time +4 hours
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Time frame: Time +6 hours
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Time frame: Time +8 hours
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
4 secondary outcomes
Describe antibiotic absorption after oral administration in these patients
Time frame: Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
Describe antibiotic absorption after oral administration in these patients
Time frame: Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
Describe antibiotic absorption after oral administration in these patients
Time frame: Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
Assess link between length of remaining bowel and antibiotic absorption
Time frame: At inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Background: PubMed 19446753Scala-Bertola J, Rabiskova M, Lecompte T, Bonneaux F, Maincent P. Granules in the improvement of oral heparin bioavailability. Int J Pharm. 2009 Jun 5;374(1-2):12-6. doi: 10.1016/j.ijpharm.2009.02.020. Epub 2009 Mar 9.
- Background: PubMed 12671903American Gastroenterological Association. American Gastroenterological Association medical position statement: short bowel syndrome and intestinal transplantation. Gastroenterology. 2003 Apr;124(4):1105-10. doi: 10.1053/gast.2003.50139. No abstract available.
- Background: PubMed 26944585Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, Joly F, Kelly D, Lal S, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM; Home Artificial Nutrition & Chronic Intestinal Failure Special Interest Group of ESPEN. ESPEN guidelines on chronic intestinal failure in adults. Clin Nutr. 2016 Apr;35(2):247-307. doi: 10.1016/j.clnu.2016.01.020. Epub 2016 Feb 8.
- Background: PubMed 17924895Gupta A, Mehta Y, Juneja R, Trehan N. The effect of cannula material on the incidence of peripheral venous thrombophlebitis. Anaesthesia. 2007 Nov;62(11):1139-42. doi: 10.1111/j.1365-2044.2007.05180.x.
- Background: PubMed 16970212Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006 Sep;81(9):1159-71. doi: 10.4065/81.9.1159.
- Results publication: PubMed 20094812Ward N. The impact of intestinal failure on oral drug absorption: a review. J Gastrointest Surg. 2010 Jun;14(6):1045-51. doi: 10.1007/s11605-009-1151-9. Epub 2010 Jan 22.
- Results publication: PubMed 2292168Vance-Bryan K, Guay DR, Rotschafer JC. Clinical pharmacokinetics of ciprofloxacin. Clin Pharmacokinet. 1990 Dec;19(6):434-61. doi: 10.2165/00003088-199019060-00003.
- Results publication: PubMed 1559306Lamp KC, Bailey EM, Rybak MJ. Ofloxacin clinical pharmacokinetics. Clin Pharmacokinet. 1992 Jan;22(1):32-46. doi: 10.2165/00003088-199222010-00004.
- Results publication: PubMed 7924123Barr WH, Zola EM, Candler EL, Hwang SM, Tendolkar AV, Shamburek R, Parker B, Hilty MD. Differential absorption of amoxicillin from the human small and large intestine. Clin Pharmacol Ther. 1994 Sep;56(3):279-85. doi: 10.1038/clpt.1994.138.
- Results publication: PubMed 15530127Severijnen R, Bayat N, Bakker H, Tolboom J, Bongaerts G. Enteral drug absorption in patients with short small bowel : a review. Clin Pharmacokinet. 2004;43(14):951-62. doi: 10.2165/00003088-200443140-00001.
- Results publication: PubMed 29127863Cheung YW, Barco S, Mathot RAA, van den Dool EJ, Stroobants AK, Serlie MJ, Middeldorp S, Coppens M. Pharmacokinetics of dabigatran etexilate and rivaroxaban in patients with short bowel syndrome requiring parenteral nutrition: The PDER PAN study. Thromb Res. 2017 Dec;160:76-82. doi: 10.1016/j.thromres.2017.10.025. Epub 2017 Nov 4.
- Results publication: PubMed 24667978Faye E, Drouet L, De Raucourt E, Green A, Bal-Dit-Sollier C, Boudaoud L, Corcos O, Bergmann JF, Joly F, Lloret-Linares C. Absorption and efficacy of acetylsalicylic acid in patients with short bowel syndrome. Ann Pharmacother. 2014 Jun;48(6):705-10. doi: 10.1177/1060028014526700. Epub 2014 Mar 25.
- Individual participant dataSharing planned: Undecided. Depending on first results, this pilot study might be extended in a new multicenter study
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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.
Elise Pape contact
Niasha MICHOT, MD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amoxicillin, Levofloxacin and Ofloxacin in people with Short Bowel Syndrome and Infection, Bacterial, run by Central Hospital, Nancy, France at 1 site 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 6 inclusion and 6 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 29 Aug 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Niasha MICHOT, MD (+33383155108, n.michot@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome (time frame: Time -0.5 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05302531, which also lists 15 linked publications.
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 29 Aug 2024.