HealthyPhase 2NCT05781490
A Healthy Volunteer Trial Investigating MR-enterography Image Quality of Lumentin® 44
A Phase 2 study testing Lumentin® 44 Powder for oral foam in people with Healthy, run by Lument AB at 1 site in Sweden.
Trial summary
A healthy volunteer, open, PoC single center trial investigating a new oral contrast agent for use in combination of MR examination of the abdomen and pelvis. The main purpose of the trial is to evaluate if Lumentin® 44 used as a bowel filling agent in MRE examination generates images with acceptable diagnostic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lumentin® 44 Powder for oral foam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jan 2023to 28 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers of either gender at least 18 years at the time of signing the informed consent.
- Females must either present a negative pregnancy test or be surgically sterile (hysterectomy or tubal ligation) or postmenopausal (i.e., experienced 12 consecutive months without menstruation).
- Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any trial related activity is carried out.
Who cannot join
- GFR below 60 ml/min/1.73 sqm body surface. All subjects will have a plasma creatinine taken at screening for calculation of eGFR.
- History of drug related reaction to gadolinium contrast agents.
- Have had gadolinium injection during the last 4 weeks.
- Claustrophobia not coping with MRE examination.
- Metal objects and medical devices in the body not judged by the investigator to be compatible with MRE.
- Hypersensitivity to Buscopan® (Butylhyoscopin).
Show all 13Show fewer
- Having swallowing difficulties.
- Known allergy to egg albumen.
- Known sensitivity to any of the components of the investigational product.
- Clinical suspicion of ongoing disease by the investigator.
- Being, in the opinion of the investigator, unlikely to comply with the clinical trial protocol.
- Previously randomized to participate in this trial.
- Participating in or having participated in another clinical trial within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Uncontrolled, Single Centre, Healthy Volunteer, Phase II Proof-of-concept Trial Investigating MR-enterography Image Quality of Lumentin® 44, a New Egg Albumen Based Oral Small Bowel Filling Contrast Agent.
A healthy volunteer, open, PoC single center trial investigating a new oral contrast agent for use in combination of MR examination of the abdomen and pelvis.
The main purpose of the trial is to evaluate if Lumentin® 44 used as a bowel filling agent in MRE examination generates images with acceptable diagnostic quality.
In addition, the plasma electrolytes concentration levels, including, potassium, sodium, phosphate, and calcium, as well as ionized calcium will be evaluated over a 24 hour time period after intake of Lumentin.
Read the detailed description
This is an uncontrolled, single centre phase II trial. Enrolled HVs (n=10) will undergo Gd-enhanced MRE after oral intake of Lumentin® 44.
Interested HVs will be identified primarily among medical students at the medical hospitals at Malmö and Lund. Posters will be placed at the departments and invitation letters will be handed out.
The HVs interested in participating will be invited to attend a pre-screening visit where their suitability based on age and health status will be assessed. Fifteen HVs who fulfil the pre-screening criteria and are interested in participating will be asked to attend a screening visit at the clinic and if eligible for the trial they will then visit the clinic for the MRE assessment within 1-2 weeks.
Only the initial 10 of the eligible HVs will be asked to come for the MRE examination and the remaining eligible subjects will be asked to stand by in case any of the 10 subjects are unable to come or cannot undergo the examination.
HVs will be asked to fast for 6 hours prior to the examination on the day of the MRE examination. Small amount of clear liquid is allowed up to 2 decilitres. Prior to MRE, Lumentin® 44 will be provided to them in volumes of up to 1,500 mL and at least 1,100 mL of Lumentin® 44 must be drunk. The subjects will be asked to drink the solutions of oral contrast agent within 45 minutes to 1 hour.
Subjects not able to drink at least 1.1 L of Lumentin® 44 will be withdrawn from the trial.
Prior to the intake of Lumentin® 44, an IV antecubital cannula will be placed and used for blood sampling and administration of gadolinium (Gd) contrast agent during the MRE assessment.
- Conditions
- Healthy
- Being tested
- Lumentin® 44 Powder for oral foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumentin® 44 Powder for oral foamDrug
Lumentin® 44 is a foam for oral use.
| Study group | Role | What they receive |
|---|---|---|
| Lumentin® 44 | Experimental | Lumentin® 44 Powder for oral foam Receives: Drug: Lumentin® 44 Powder for oral foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Evaluation of MRE Images - Motility
Motility: MRE examinations with Lumentin® 44 will be scored with respect to motility status based on a 5-graded scale, as follows:
- No motility could be assessed
- Motility is assessed to some degree but less good than conventional MRE
- Motility is assessed to same degree as conventional MRE
- Motility is assessed somewhat better than conventional MRE
- Motility is assessed better than conventional MRE Motility should be evaluated as a whole in the specific cine- sequences and resulting in one ordinal score 1-5. A high score indicate a better outcome.
Measured: Day 1
Visual Evaluation of MRE Images -Artefacts
Artefacts: MRE examinations with Lumentin® 44 will be scored with respect to artefacts based on a 5-graded scale, as follows:
- Severe deteriorating artefacts in the interface between the lumen and wall
- Disturbing artefacts in the interface between the lumen and wall less good compared to conventional MRE
- Medium artefacts in the interface between the lumen and wall, same as for conventional MRE
- Small artefacts that give minimal bright edges in the interface between the lumen and wall, somewhat better than conventional MRE
- No artefacts and better than conventional MRE Artefacts should be evaluated as a whole in all sequences and resulting in one ordinal score 1-5. A high score indicate a better outcome.
Measured: Day 1
Visual Evaluation of MRE Images -Mucosal Evaluation
Mucosal evaluation: MRE examinations with Lumentin® 44 will be scored with respect to mucosal status based on a 5-graded scale, as follows:
- No mucosal folds are seen
- Some small mucosal folds can be discriminated
- Mucosal folds can be discriminated, same as for conventional MRE
- Small mucosal folds can be discriminated, somewhat better than for conventional MRE
- Mucosal folds are seen in detail and better than conventional MRE Mucosal evaluation a) coronal and b) axial T1 gradient-echo with Gd should be done and resulting in one ordinal score 1-5. A high score indicate a better outcome.
Measured: Day 1
Visual Evaluation of MRE Images -Overall Diagnostic Impression
Overall diagnostic impression: MRE examinations with Lumentin® 44 will be graded for global quality of the information obtained with special reference to diagnostic purposes, as follows:
- Poor diagnostic quality
- Medium diagnostic quality, below conventional MRE
- Good diagnostic quality, same as for conventional MRE
- Very good diagnostic quality, somewhat better than conventional MRE
- Excellent diagnostic quality, better than conventional MRE The quality of the whole examination and what the impression is for using the examination for diagnostic purposes will be graded on a scale 1-5. A high score indicate a better outcome.
Measured: Day 1
Secondary outcomes (14)
Concentration of Plasma Sodium
Concentration of plasma sodium levels over time
Measured: Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h)
Concentration of Plasma Potassium
Concentration of plasma potassium levels over time
Measured: Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h)
Concentration of Plasma Phosphate
Concentration of plasma phosphate levels over time
Measured: Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h)
Concentration of Serum Ionized Calcium
Concentration of serum ionized calcium levels over time
Measured: Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h)
Bowel Filling Properties: Extension/Duodenum
Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
- Extension: 1 is no filling and 5 is filled completely
- Distension of the segment of small bowel: 1 is no distension and 5 is optimal distension
Measured: MR examination, Day 1
Bowel Filling Properties: Extension/Jejunum
Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
- Extension: 1 is no filling and 5 is filled completely
- Distension of the segment of small bowel: 1 is no distension and 5 is optimal distension
Measured: MR examination, Day 1
Bowel Filling Properties: Extension/Proximal Ileum
Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
- Extension: 1 is no filling and 5 is filled completely
- Distension of the segment of small bowel: 1 is no distension and 5 is optimal distension
Measured: MR examination, Day 1
Bowel Filling Properties: Extension/Distal Ileum
Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
- Extension: 1 is no filling and 5 is filled completely
- Distension of the segment of small bowel: 1 is no distension and 5 is optimal distension
Measured: MR examination, Day 1
Bowel Filling Properties: Extension/Terminal Ileum
Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
- Extension: 1 is no filling and 5 is filled completely
- Distension of the segment of small bowel: 1 is no distension and 5 is optimal distension
Measured: MR examination, Day 1
Bowel Filling Properties: Distension/Duodenum
Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
- Extension: 1 is no filling and 5 is filled completely
- Distension of the segment of small bowel: 1 is no distension and 5 is optimal distension
Measured: MR examination, Day 1
Bowel Filling Properties: Distension/Jejunum
Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
- Extension: 1 is no filling and 5 is filled completely
- Distension of the segment of small bowel: 1 is no distension and 5 is optimal distension
Measured: MR examination, Day 1
Bowel Filling Properties: Distension/Proximal Ileum
Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
- Extension: 1 is no filling and 5 is filled completely
- Distension of the segment of small bowel: 1 is no distension and 5 is optimal distension
Measured: MR examination, Day 1
Bowel Filling Properties: Distension/Distal Ileum
Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
- Extension: 1 is no filling and 5 is filled completely
- Distension of the segment of small bowel: 1 is no distension and 5 is optimal distension
Measured: MR examination, Day 1
Bowel Filling Properties: Distension/Terminal Ileum
Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
- Extension: 1 is no filling and 5 is filled completely
- Distension of the segment of small bowel: 1 is no distension and 5 is optimal distension
Measured: MR examination, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start15 Jan 2023
- Primary completion15 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lument AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Q Clinical Research AB
- Responsible party
- Sponsor
- Investigators
- Peter Leander, Principal investigator, PeritusClinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781490
- Sponsor's protocol ID
- LUMRIS-001
- Other IDs
- 2022-002193-84
- Status last verified
- Jan 2024
- First submitted
- 9 Feb 2023
- Last updated
- 19 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Uncontrolled, Single Centre, Healthy Volunteer, Phase II Proof-of-concept Trial Investigating MR-enterography Image Quality of Lumentin® 44, a New Egg Albumen Based Oral Small Bowel Filling Contrast Agent.
- ClinicalTrials.gov ID
- NCT05781490
- Acronym / sponsor ID
- LUMRIS-001
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lument ABIndustry (pharma, biotech, devices)
- Collaborators
- Q Clinical Research AB
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Posted 19 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A healthy volunteer, open, PoC single center trial investigating a new oral contrast agent for use in combination of MR examination of the abdomen and pelvis.
The main purpose of the trial is to evaluate if Lumentin® 44 used as a bowel filling agent in MRE examination generates images with acceptable diagnostic quality.
In addition, the plasma electrolytes concentration levels, including, potassium, sodium, phosphate, and calcium, as well as ionized calcium will be evaluated over a 24 hour time period after intake of Lumentin.
Detailed description
This is an uncontrolled, single centre phase II trial. Enrolled HVs (n=10) will undergo Gd-enhanced MRE after oral intake of Lumentin® 44.
Interested HVs will be identified primarily among medical students at the medical hospitals at Malmö and Lund. Posters will be placed at the departments and invitation letters will be handed out.
The HVs interested in participating will be invited to attend a pre-screening visit where their suitability based on age and health status will be assessed. Fifteen HVs who fulfil the pre-screening criteria and are interested in participating will be asked to attend a screening visit at the clinic and if eligible for the trial they will then visit the clinic for the MRE assessment within 1-2 weeks.
Only the initial 10 of the eligible HVs will be asked to come for the MRE examination and the remaining eligible subjects will be asked to stand by in case any of the 10 subjects are unable to come or cannot undergo the examination.
HVs will be asked to fast for 6 hours prior to the examination on the day of the MRE examination. Small amount of clear liquid is allowed up to 2 decilitres. Prior to MRE, Lumentin® 44 will be provided to them in volumes of up to 1,500 mL and at least 1,100 mL of Lumentin® 44 must be drunk. The subjects will be asked to drink the solutions of oral contrast agent within 45 minutes to 1 hour.
Subjects not able to drink at least 1.1 L of Lumentin® 44 will be withdrawn from the trial.
Prior to the intake of Lumentin® 44, an IV antecubital cannula will be placed and used for blood sampling and administration of gadolinium (Gd) contrast agent during the MRE assessment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumentin® 44 | Experimental | Drug: Lumentin® 44 Powder for oral foamLumentin® 44 Powder for oral foam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers of either gender at least 18 years at the time of signing the informed consent.
- Females must either present a negative pregnancy test or be surgically sterile (hysterectomy or tubal ligation) or postmenopausal (i.e., experienced 12 consecutive months without menstruation).
- Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any trial related activity is carried out.
Key exclusion criteria (13 listed)
- GFR below 60 ml/min/1.73 sqm body surface. All subjects will have a plasma creatinine taken at screening for calculation of eGFR.
- History of drug related reaction to gadolinium contrast agents.
- Have had gadolinium injection during the last 4 weeks.
- Claustrophobia not coping with MRE examination.
- Metal objects and medical devices in the body not judged by the investigator to be compatible with MRE.
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 |
|---|---|---|
| Lumentin® 44 Powder for oral foamLumentin® 44 is a foam for oral use. | Drug | Lumentin® 44 |
Primary outcome
Visual Evaluation of MRE Images - Motility
Time frame: Day 1
Motility: MRE examinations with Lumentin® 44 will be scored with respect to motility status based on a 5-graded scale, as follows: 1. No motility could be assessed 2. Motility is assessed to some degree but less good than conventional MRE 3. Motility is assessed to same degree as conventional MRE 4. Motility is assessed somewhat better than conventional MRE 5. Motility is assessed better than conventional MRE Motility should be evaluated as a whole in the specific cine- sequences and resulting in one ordinal score 1-5. A high score indicate a better outcome.
Visual Evaluation of MRE Images -Artefacts
Time frame: Day 1
Artefacts: MRE examinations with Lumentin® 44 will be scored with respect to artefacts based on a 5-graded scale, as follows: 1. Severe deteriorating artefacts in the interface between the lumen and wall 2. Disturbing artefacts in the interface between the lumen and wall less good compared to conventional MRE 3. Medium artefacts in the interface between the lumen and wall, same as for conventional MRE 4. Small artefacts that give minimal bright edges in the interface between the lumen and wall, somewhat better than conventional MRE 5. No artefacts and better than conventional MRE Artefacts should be evaluated as a whole in all sequences and resulting in one ordinal score 1-5. A high score indicate a better outcome.
Visual Evaluation of MRE Images -Mucosal Evaluation
Time frame: Day 1
Mucosal evaluation: MRE examinations with Lumentin® 44 will be scored with respect to mucosal status based on a 5-graded scale, as follows: 1. No mucosal folds are seen 2. Some small mucosal folds can be discriminated 3. Mucosal folds can be discriminated, same as for conventional MRE 4. Small mucosal folds can be discriminated, somewhat better than for conventional MRE 5. Mucosal folds are seen in detail and better than conventional MRE Mucosal evaluation a) coronal and b) axial T1 gradient-echo with Gd should be done and resulting in one ordinal score 1-5. A high score indicate a better outcome.
Visual Evaluation of MRE Images -Overall Diagnostic Impression
Time frame: Day 1
Overall diagnostic impression: MRE examinations with Lumentin® 44 will be graded for global quality of the information obtained with special reference to diagnostic purposes, as follows: 1. Poor diagnostic quality 2. Medium diagnostic quality, below conventional MRE 3. Good diagnostic quality, same as for conventional MRE 4. Very good diagnostic quality, somewhat better than conventional MRE 5. Excellent diagnostic quality, better than conventional MRE The quality of the whole examination and what the impression is for using the examination for diagnostic purposes will be graded on a scale 1-5. A high score indicate a better outcome.
14 secondary outcomes
Concentration of Plasma Sodium
Time frame: Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h)
Concentration of Plasma Potassium
Time frame: Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h)
Concentration of Plasma Phosphate
Time frame: Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h)
Concentration of Serum Ionized Calcium
Time frame: Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h)
Bowel Filling Properties: Extension/Duodenum
Time frame: MR examination, Day 1
Bowel Filling Properties: Extension/Jejunum
Time frame: MR examination, Day 1
Bowel Filling Properties: Extension/Proximal Ileum
Time frame: MR examination, Day 1
Bowel Filling Properties: Extension/Distal Ileum
Time frame: MR examination, Day 1
Bowel Filling Properties: Extension/Terminal Ileum
Time frame: MR examination, Day 1
Bowel Filling Properties: Distension/Duodenum
Time frame: MR examination, Day 1
Bowel Filling Properties: Distension/Jejunum
Time frame: MR examination, Day 1
Bowel Filling Properties: Distension/Proximal Ileum
Time frame: MR examination, Day 1
Bowel Filling Properties: Distension/Distal Ileum
Time frame: MR examination, Day 1
Bowel Filling Properties: Distension/Terminal Ileum
Time frame: MR examination, Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Leander principal investigator
PeritusClinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lumentin® 44 Powder for oral foam in people with Healthy, run by Lument AB at 1 site in Sweden.
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 13 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: finished, as of the sponsor's last update on 19 Jul 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 Sweden. 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 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?
Yes. Results are posted in the registry (first posted 19 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Evaluation of MRE Images - Motility (time frame: Day 1). The study lists 4 primary outcomes in all. 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 19 Jul 2024.