Trial Outcomes & Findings for CampETEC Hyperimmune Bovine Colostrum (HBC) (NCT NCT06122870)
NCT ID: NCT06122870
Last Updated: 2025-08-22
Results Overview
The primary safety and tolerability outcome is the presence of CampETEC HBC associated adverse events during the study period. Safety of CampETEC HBC.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
28 days
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
CampETEC HBC Group
CampETEC HBC (hyper immune bovine colostrum) and challenge strain C. jejuni CG8421
CampETEC HBC product: Immunoglobulin from bovine milk/colostrum and challenge strain
C. jejuni CG8421 Challenge strain: Challenge strain C. jejuni CG8421
|
Placebo ProMilk 85 Group
ProMilk 85 (placebo) and challenge strain C.jejuni CG8421
ProMilk 85: Placebo ProMilk 85
C. jejuni CG8421 Challenge strain: Challenge strain C. jejuni CG8421
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CampETEC Hyperimmune Bovine Colostrum (HBC)
Baseline characteristics by cohort
| Measure |
CampETEC HBC Group
n=13 Participants
CampETEC HBC (hyper immune bovine colostrum) and challenge strain C. jejuni CG8421
CampETEC HBC product: Immunoglobulin from bovine milk/colostrum and challenge strain
C. jejuni CG8421 Challenge strain: Challenge strain C. jejuni CG8421
|
Placebo ProMilk 85 Group
n=14 Participants
ProMilk 85 (placebo) and challenge strain C.jejuni CG8421
ProMilk 85: Placebo ProMilk 85
C. jejuni CG8421 Challenge strain: Challenge strain C. jejuni CG8421
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysThe primary safety and tolerability outcome is the presence of CampETEC HBC associated adverse events during the study period. Safety of CampETEC HBC.
Outcome measures
| Measure |
CampETEC HBC Group
n=13 Participants
CampETEC HBC (hyper immune bovine colostrum) and challenge strain C. jejuni CG8421
CampETEC HBC product: Immunoglobulin from bovine milk/colostrum and challenge strain
C. jejuni CG8421 Challenge strain: Challenge strain C. jejuni CG8421
|
Placebo ProMilk 85 Group
n=14 Participants
ProMilk 85 (placebo) and challenge strain C.jejuni CG8421
ProMilk 85: Placebo ProMilk 85
C. jejuni CG8421 Challenge strain: Challenge strain C. jejuni CG8421
|
|---|---|---|
|
Incidence of Adverse Events
Abdominal distention
|
1 events
Interval 0.2 to 36.0
|
1 events
Interval 0.2 to 33.9
|
|
Incidence of Adverse Events
Defaecation urgency
|
0 events
Interval 0.0 to 24.7
|
1 events
Interval 0.2 to 33.9
|
|
Incidence of Adverse Events
Flatulence
|
2 events
Interval 1.9 to 45.4
|
2 events
Interval 1.8 to 42.8
|
|
Incidence of Adverse Events
Gastrointestinal sounds abnormal
|
0 events
Interval 0.0 to 24.7
|
1 events
Interval 0.2 to 33.9
|
|
Incidence of Adverse Events
Dizziness
|
0 events
Interval 0.0 to 24.7
|
1 events
Interval 0.2 to 33.9
|
PRIMARY outcome
Timeframe: Within 144 hours of challengeThe primary efficacy outcome is campylobacteriosis, defined as a clinical illness meeting at least one of the following patterns starting within 144 hours of challenge * Moderate diarrhea (4 to 5 loose/liquid stools or 401-800 grams in any 24 hour period) OR * Severe diarrhea (≥ 6 loose/liquid stools or \> 800 grams in any 24 hour period) OR * Fever (present on at least 2 occasions, at least 20 minutes apart) without diarrhea, plus an associated symptom (nausea, vomiting, abdominal cramps, tenesmus, or dysentery (gross blood in ≥ 2 grade 3 - 5 stools with in any 24 hour period); with consideration of potential alternative diagnosis per clinical investigator based on illness time course and associated symptoms.
Outcome measures
| Measure |
CampETEC HBC Group
n=13 Participants
CampETEC HBC (hyper immune bovine colostrum) and challenge strain C. jejuni CG8421
CampETEC HBC product: Immunoglobulin from bovine milk/colostrum and challenge strain
C. jejuni CG8421 Challenge strain: Challenge strain C. jejuni CG8421
|
Placebo ProMilk 85 Group
n=14 Participants
ProMilk 85 (placebo) and challenge strain C.jejuni CG8421
ProMilk 85: Placebo ProMilk 85
C. jejuni CG8421 Challenge strain: Challenge strain C. jejuni CG8421
|
|---|---|---|
|
Number of Participants With Campylobacteriosis Patterns
Campylobacteriosis
|
10 Participants
|
12 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
Any Diarrhea
|
10 Participants
|
11 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
Mild Diarrhea
|
0 Participants
|
0 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
Moderate Diarrhea
|
4 Participants
|
4 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
Severe Diarrhea
|
6 Participants
|
7 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
Dysentery
|
1 Participants
|
1 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
Moderate/Severe Fever
|
4 Participants
|
5 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
Moderate/Severe Abdominal Pain/Cramps
|
7 Participants
|
6 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
Moderate/Severe Nausea
|
3 Participants
|
3 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
Moderate/Severe Vomiting
|
0 Participants
|
0 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
Moderate/Severe Anorexia
|
4 Participants
|
3 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
Early Antibiotic Treatment Required
|
6 Participants
|
7 Participants
|
|
Number of Participants With Campylobacteriosis Patterns
IV Fluids Required
|
1 Participants
|
3 Participants
|
Adverse Events
CampETEC HBC Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo ProMilk 85 Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CampETEC HBC Group
n=13 participants at risk
CampETEC HBC (hyper immune bovine colostrum) and challenge strain C. jejuni CG8421
CampETEC HBC product: Immunoglobulin from bovine milk/colostrum and challenge strain
C. jejuni CG8421 Challenge strain: Challenge strain C. jejuni CG8421
|
Placebo ProMilk 85 Group
n=14 participants at risk
ProMilk 85 (placebo) and challenge strain C.jejuni CG8421
ProMilk 85: Placebo ProMilk 85
C. jejuni CG8421 Challenge strain: Challenge strain C. jejuni CG8421
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
7.7%
1/13 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
7.1%
1/14 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Defaecation Urgency
|
0.00%
0/13 • 28 days after Challenge
CampETEC related Adverse Events
|
7.1%
1/14 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Flatulence
|
53.8%
7/13 • Number of events 7 • 28 days after Challenge
CampETEC related Adverse Events
|
42.9%
6/14 • Number of events 6 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
15.4%
2/13 • Number of events 2 • 28 days after Challenge
CampETEC related Adverse Events
|
14.3%
2/14 • Number of events 2 • 28 days after Challenge
CampETEC related Adverse Events
|
|
General disorders
Dizziness
|
0.00%
0/13 • 28 days after Challenge
CampETEC related Adverse Events
|
7.1%
1/14 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/13 • 28 days after Challenge
CampETEC related Adverse Events
|
7.1%
1/14 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13 • Number of events 5 • 28 days after Challenge
CampETEC related Adverse Events
|
21.4%
3/14 • Number of events 3 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Infections and infestations
Vulvovaginal candidacies
|
7.7%
1/13 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
0.00%
0/14 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • 28 days after Challenge
CampETEC related Adverse Events
|
7.1%
1/14 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Eye disorders
Photophobia
|
7.7%
1/13 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
0.00%
0/14 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Abdominal distension
|
30.8%
4/13 • Number of events 4 • 28 days after Challenge
CampETEC related Adverse Events
|
35.7%
5/14 • Number of events 5 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain
|
76.9%
10/13 • Number of events 10 • 28 days after Challenge
CampETEC related Adverse Events
|
57.1%
8/14 • Number of events 8 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Abdominal rebound tenderness
|
7.7%
1/13 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
0.00%
0/14 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Abdominal tenderness
|
38.5%
5/13 • Number of events 5 • 28 days after Challenge
CampETEC related Adverse Events
|
14.3%
2/14 • Number of events 2 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13 • Number of events 3 • 28 days after Challenge
CampETEC related Adverse Events
|
7.1%
1/14 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Defaecation urgency
|
38.5%
5/13 • Number of events 5 • 28 days after Challenge
CampETEC related Adverse Events
|
42.9%
6/14 • Number of events 6 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.7%
1/13 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
0.00%
0/14 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/13 • 28 days after Challenge
CampETEC related Adverse Events
|
7.1%
1/14 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • 28 days after Challenge
CampETEC related Adverse Events
|
7.1%
1/14 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
|
General disorders
Chills
|
53.8%
7/13 • Number of events 7 • 28 days after Challenge
CampETEC related Adverse Events
|
50.0%
7/14 • Number of events 7 • 28 days after Challenge
CampETEC related Adverse Events
|
|
General disorders
Malaise
|
61.5%
8/13 • Number of events 8 • 28 days after Challenge
CampETEC related Adverse Events
|
57.1%
8/14 • Number of events 8 • 28 days after Challenge
CampETEC related Adverse Events
|
|
General disorders
Pyrexia
|
46.2%
6/13 • Number of events 6 • 28 days after Challenge
CampETEC related Adverse Events
|
35.7%
5/14 • Number of events 5 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Infections and infestations
Dysentery
|
7.7%
1/13 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
7.1%
1/14 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Investigations
Blood pressure decreased
|
0.00%
0/13 • 28 days after Challenge
CampETEC related Adverse Events
|
7.1%
1/14 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Investigations
Heart rate increased
|
23.1%
3/13 • Number of events 3 • 28 days after Challenge
CampETEC related Adverse Events
|
28.6%
4/14 • Number of events 4 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
46.2%
6/13 • Number of events 6 • 28 days after Challenge
CampETEC related Adverse Events
|
50.0%
7/14 • Number of events 7 • 28 days after Challenge
CampETEC related Adverse Events
|
|
General disorders
Hypovolemia
|
7.7%
1/13 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
7.1%
1/14 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
28.6%
4/14 • Number of events 4 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Number of events 1 • 28 days after Challenge
CampETEC related Adverse Events
|
0.00%
0/14 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
46.2%
6/13 • Number of events 6 • 28 days after Challenge
CampETEC related Adverse Events
|
64.3%
9/14 • Number of events 9 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Nervous system disorders
Dizziness
|
38.5%
5/13 • Number of events 5 • 28 days after Challenge
CampETEC related Adverse Events
|
21.4%
3/14 • Number of events 3 • 28 days after Challenge
CampETEC related Adverse Events
|
|
Nervous system disorders
Headache
|
46.2%
6/13 • Number of events 6 • 28 days after Challenge
CampETEC related Adverse Events
|
78.6%
11/14 • Number of events 11 • 28 days after Challenge
CampETEC related Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place