Trial Outcomes & Findings for A Healthy Volunteer Trial Investigating MR-enterography Image Quality of Lumentin® 44 (NCT NCT05781490)
NCT ID: NCT05781490
Last Updated: 2024-07-19
Results Overview
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.
COMPLETED
PHASE2
10 participants
Day 1
2024-07-19
Participant Flow
Participant milestones
| Measure |
Lumentin® 44
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
|
Region of Enrollment
Sweden
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed
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.
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Visual Evaluation of MRE Images - Motility
No motility could be assessed
|
0 Participants
|
|
Visual Evaluation of MRE Images - Motility
Motility is assessed to some degree but less good than conventional MRE
|
6 Participants
|
|
Visual Evaluation of MRE Images - Motility
Motility is assessed to same degree as conventional MRE
|
4 Participants
|
|
Visual Evaluation of MRE Images - Motility
Motility is assessed somewhat better than conventional MRE
|
0 Participants
|
|
Visual Evaluation of MRE Images - Motility
Motility is assessed better than conventional MRE
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed
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.
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Visual Evaluation of MRE Images -Artefacts
Severe deteriorating artefacts in the interface between the lumen and wall
|
0 Participants
|
|
Visual Evaluation of MRE Images -Artefacts
Disturbing artefacts in the interface between lumen and wall less good compared to conventional MRE
|
5 Participants
|
|
Visual Evaluation of MRE Images -Artefacts
Medium artefacts in the interface between the lumen and wall, same as for conventional MRE
|
5 Participants
|
|
Visual Evaluation of MRE Images -Artefacts
Small artefacts, minimal bright edges in the interface between lumen/wall, somewhat better than MRE
|
0 Participants
|
|
Visual Evaluation of MRE Images -Artefacts
No artefacts and better than conventional MRE
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed
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.
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Visual Evaluation of MRE Images -Mucosal Evaluation
No mucosal folds are seen
|
0 Participants
|
|
Visual Evaluation of MRE Images -Mucosal Evaluation
Some small mucosal folds can be discriminated
|
6 Participants
|
|
Visual Evaluation of MRE Images -Mucosal Evaluation
Mucosal folds can be discriminated, same as for conventional MRE
|
4 Participants
|
|
Visual Evaluation of MRE Images -Mucosal Evaluation
Small mucosal folds can be discriminated, somewhat better than for conventional MRE
|
0 Participants
|
|
Visual Evaluation of MRE Images -Mucosal Evaluation
Mucosal folds are seen in detail and better than conventional MRE
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed
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.
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Visual Evaluation of MRE Images -Overall Diagnostic Impression
Poor diagnostic quality
|
0 Participants
|
|
Visual Evaluation of MRE Images -Overall Diagnostic Impression
Medium diagnostic quality, below conventional MRE
|
7 Participants
|
|
Visual Evaluation of MRE Images -Overall Diagnostic Impression
Good diagnostic quality, same as for conventional MRE
|
3 Participants
|
|
Visual Evaluation of MRE Images -Overall Diagnostic Impression
Very good diagnostic quality, somewhat better than conventional MRE
|
0 Participants
|
|
Visual Evaluation of MRE Images -Overall Diagnostic Impression
Excellent diagnostic quality, better than conventional MRE
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 sodium levels over time
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Concentration of Plasma Sodium
T0h
|
139.70 mmol/L
Standard Deviation 1.57
|
|
Concentration of Plasma Sodium
T1h
|
139.90 mmol/L
Standard Deviation 1.20
|
|
Concentration of Plasma Sodium
T2h
|
140.30 mmol/L
Standard Deviation 2.00
|
|
Concentration of Plasma Sodium
T4h
|
146.60 mmol/L
Standard Deviation 1.58
|
|
Concentration of Plasma Sodium
T6h
|
140.70 mmol/L
Standard Deviation 1.83
|
|
Concentration of Plasma Sodium
T8h
|
140.30 mmol/L
Standard Deviation 1.57
|
|
Concentration of Plasma Sodium
T24h
|
139.80 mmol/L
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: 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)Population: Blood samples at various time points could not be analysed due to error in handling of samples.
Concentration of plasma potassium levels over time
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Concentration of Plasma Potassium
T0h
|
4.04 mmol/L
Standard Deviation 0.22
|
|
Concentration of Plasma Potassium
T1h
|
4.47 mmol/L
Standard Deviation 0.24
|
|
Concentration of Plasma Potassium
T2h
|
4.35 mmol/L
Standard Deviation 0.24
|
|
Concentration of Plasma Potassium
T4h
|
4.16 mmol/L
Standard Deviation 0.20
|
|
Concentration of Plasma Potassium
T6h
|
4.14 mmol/L
Standard Deviation 0.15
|
|
Concentration of Plasma Potassium
T8h
|
4.08 mmol/L
Standard Deviation 0.17
|
|
Concentration of Plasma Potassium
T24h
|
4.10 mmol/L
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: 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 levels over time
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Concentration of Plasma Phosphate
T0h
|
1.05 mmol/L
Standard Deviation 0.31
|
|
Concentration of Plasma Phosphate
T1h
|
1.22 mmol/L
Standard Deviation 0.26
|
|
Concentration of Plasma Phosphate
T2h
|
1.35 mmol/L
Standard Deviation 0.28
|
|
Concentration of Plasma Phosphate
T4h
|
1.32 mmol/L
Standard Deviation 0.27
|
|
Concentration of Plasma Phosphate
T6h
|
1.31 mmol/L
Standard Deviation 0.21
|
|
Concentration of Plasma Phosphate
T8h
|
1.32 mmol/L
Standard Deviation 0.18
|
|
Concentration of Plasma Phosphate
T24
|
1.04 mmol/L
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: 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)Population: Blood samples at various time points could not be analysed due to error in handling of samples.
Concentration of serum ionized calcium levels over time
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Concentration of Serum Ionized Calcium
T0h
|
1.28 mmol/L
Standard Deviation 0.03
|
|
Concentration of Serum Ionized Calcium
T1h
|
1.26 mmol/L
Standard Deviation 0.03
|
|
Concentration of Serum Ionized Calcium
T2h
|
1.24 mmol/L
Standard Deviation 0.04
|
|
Concentration of Serum Ionized Calcium
T4h
|
1.26 mmol/L
Standard Deviation 0.03
|
|
Concentration of Serum Ionized Calcium
T6h
|
1.24 mmol/L
Standard Deviation 0.04
|
|
Concentration of Serum Ionized Calcium
T8h
|
1.23 mmol/L
Standard Deviation 0.02
|
|
Concentration of Serum Ionized Calcium
T24h
|
1.28 mmol/L
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: MR examination, Day 1Bowel 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
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Bowel Filling Properties: Extension/Duodenum
Extension/duodenum, Score 1
|
0 Participants
|
|
Bowel Filling Properties: Extension/Duodenum
Extension/duodenum, Score 2
|
0 Participants
|
|
Bowel Filling Properties: Extension/Duodenum
Extension/duodenum, Score 3
|
0 Participants
|
|
Bowel Filling Properties: Extension/Duodenum
Extension/duodenum, Score 4
|
0 Participants
|
|
Bowel Filling Properties: Extension/Duodenum
Extension/duodenum, Score 5
|
10 Participants
|
SECONDARY outcome
Timeframe: MR examination, Day 1Bowel 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
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Bowel Filling Properties: Extension/Jejunum
Extension/jejunum, score 1
|
0 Participants
|
|
Bowel Filling Properties: Extension/Jejunum
Extension/jejunum, score 2
|
0 Participants
|
|
Bowel Filling Properties: Extension/Jejunum
Extension/jejunum, score 3
|
0 Participants
|
|
Bowel Filling Properties: Extension/Jejunum
Extension/jejunum, score 4
|
0 Participants
|
|
Bowel Filling Properties: Extension/Jejunum
Extension/jejunum, score 5
|
10 Participants
|
SECONDARY outcome
Timeframe: MR examination, Day 1Bowel 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
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Bowel Filling Properties: Extension/Proximal Ileum
Extension/proximal ileum, score 1
|
0 Participants
|
|
Bowel Filling Properties: Extension/Proximal Ileum
Extension/proximal ileum, score 2
|
0 Participants
|
|
Bowel Filling Properties: Extension/Proximal Ileum
Extension/proximal ileum, score 3
|
1 Participants
|
|
Bowel Filling Properties: Extension/Proximal Ileum
Extension/proximal ileum, score 4
|
0 Participants
|
|
Bowel Filling Properties: Extension/Proximal Ileum
Extension/proximal ileum, score 5
|
9 Participants
|
SECONDARY outcome
Timeframe: MR examination, Day 1Bowel 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
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Bowel Filling Properties: Extension/Distal Ileum
Extension/Distal ileum, score 1
|
1 Participants
|
|
Bowel Filling Properties: Extension/Distal Ileum
Extension/Distal ileum, score 2
|
0 Participants
|
|
Bowel Filling Properties: Extension/Distal Ileum
Extension/Distal ileum, score 3
|
0 Participants
|
|
Bowel Filling Properties: Extension/Distal Ileum
Extension/Distal ileum, score 4
|
0 Participants
|
|
Bowel Filling Properties: Extension/Distal Ileum
Extension/Distal ileum, score 5
|
9 Participants
|
SECONDARY outcome
Timeframe: MR examination, Day 1Bowel 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
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Bowel Filling Properties: Extension/Terminal Ileum
Extension/terminal ileum, score 1
|
3 Participants
|
|
Bowel Filling Properties: Extension/Terminal Ileum
Extension/terminal ileum, score 2
|
0 Participants
|
|
Bowel Filling Properties: Extension/Terminal Ileum
Extension/terminal ileum, score 3
|
0 Participants
|
|
Bowel Filling Properties: Extension/Terminal Ileum
Extension/terminal ileum, score 4
|
0 Participants
|
|
Bowel Filling Properties: Extension/Terminal Ileum
Extension/terminal ileum, score 5
|
7 Participants
|
SECONDARY outcome
Timeframe: MR examination, Day 1Bowel 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
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Bowel Filling Properties: Distension/Duodenum
Distension/duodenum, Score 1
|
0 Participants
|
|
Bowel Filling Properties: Distension/Duodenum
Distension/duodenum, Score 2
|
0 Participants
|
|
Bowel Filling Properties: Distension/Duodenum
Distension/duodenum, Score 3
|
2 Participants
|
|
Bowel Filling Properties: Distension/Duodenum
Distension/duodenum, Score 4
|
5 Participants
|
|
Bowel Filling Properties: Distension/Duodenum
Distension/duodenum, Score 5
|
3 Participants
|
SECONDARY outcome
Timeframe: MR examination, Day 1Bowel 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
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Bowel Filling Properties: Distension/Jejunum
Distension/jejunum, Score 1
|
0 Participants
|
|
Bowel Filling Properties: Distension/Jejunum
Distension/jejunum, Score 2
|
0 Participants
|
|
Bowel Filling Properties: Distension/Jejunum
Distension/jejunum, Score 3
|
5 Participants
|
|
Bowel Filling Properties: Distension/Jejunum
Distension/jejunum, Score 4
|
5 Participants
|
|
Bowel Filling Properties: Distension/Jejunum
Distension/jejunum, Score 5
|
0 Participants
|
SECONDARY outcome
Timeframe: MR examination, Day 1Bowel 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
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Bowel Filling Properties: Distension/Proximal Ileum
Distension/proximal ileum, score 1
|
0 Participants
|
|
Bowel Filling Properties: Distension/Proximal Ileum
Distension/proximal ileum, score 2
|
0 Participants
|
|
Bowel Filling Properties: Distension/Proximal Ileum
Distension/proximal ileum, score 3
|
1 Participants
|
|
Bowel Filling Properties: Distension/Proximal Ileum
Distension/proximal ileum, score 4
|
3 Participants
|
|
Bowel Filling Properties: Distension/Proximal Ileum
Distension/proximal ileum, score 5
|
6 Participants
|
SECONDARY outcome
Timeframe: MR examination, Day 1Bowel 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
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Bowel Filling Properties: Distension/Distal Ileum
Distension/distal ileum, score 1
|
1 Participants
|
|
Bowel Filling Properties: Distension/Distal Ileum
Distension/distal ileum, score 2
|
0 Participants
|
|
Bowel Filling Properties: Distension/Distal Ileum
Distension/distal ileum, score 3
|
0 Participants
|
|
Bowel Filling Properties: Distension/Distal Ileum
Distension/distal ileum, score 4
|
1 Participants
|
|
Bowel Filling Properties: Distension/Distal Ileum
Distension/distal ileum, score 5
|
8 Participants
|
SECONDARY outcome
Timeframe: MR examination, Day 1Bowel 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
Outcome measures
| Measure |
Lumentin® 44
n=10 Participants
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Bowel Filling Properties: Distension/Terminal Ileum
Distension/terminal ileum, score 1
|
3 Participants
|
|
Bowel Filling Properties: Distension/Terminal Ileum
Distension/terminal ileum, score 2
|
0 Participants
|
|
Bowel Filling Properties: Distension/Terminal Ileum
Distension/terminal ileum, score 3
|
0 Participants
|
|
Bowel Filling Properties: Distension/Terminal Ileum
Distension/terminal ileum, score 4
|
3 Participants
|
|
Bowel Filling Properties: Distension/Terminal Ileum
Distension/terminal ileum, score 5
|
4 Participants
|
Adverse Events
Lumentin® 44
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lumentin® 44
n=10 participants at risk
Lumentin® 44 Powder for oral foam
Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • From start of intake of study medication and 2 days after treatment. Trial subjects were in the trial between 23 JAN 2023 and 17 FEB 2023
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place